At Prothya, we believe great people drive great success. To support our growing organization, we are looking for a Junior Talent Acquisition Specialist with a genuine interest in recruitment, HR and the pharmaceutical industry. In this role, you will support end-to-end recruitment activities in the Netherlands, with occasional involvement in Belgium.

You will work closely with the Talent Acquisition team, hiring managers, HR Business Partners, and our Managed Service Provider (MSP), ensuring a smooth, compliant, and high-quality recruitment process. This role offers the opportunity to grow into a trusted recruitment partner within a complex and impactful organization.

What you’ll do

• Support the full recruitment lifecycle, from intake to offer stage
• Partner closely with hiring managers and the MSP to manage open vacancies
• Source and screen candidates using multiple channels, including LinkedIn
• Coordinate interviews and ensure a positive candidate experience
• Maintain accurate recruitment administration and reporting in HR systems
• Contribute to employer branding initiatives and recruitment projects
• Operate within a regulated (GxP) pharmaceutical environment

What you’ll bring

• Minimum 2 years of relevant work experience in recruitment, Talent Acquisition, HR, or a related field
• Strong interest in, or affinity with, the pharmaceutical or life sciences industry
• Bachelor’s degree or Bachelor working and thinking level
• Experience with HR or recruitment systems (e.g. AFAS, SAP SuccessFactors, or similar)
• Basic knowledge of sourcing techniques, including LinkedIn Boolean search, is a plus
• Strong organisational and communication skills
• Fluency in Dutch and English
• A proactive, structured, and collaborative mindset

Why Prothya?

You will join a purpose-driven pharmaceutical organization where your work directly supports life-changing therapies. Prothya offers a professional, learning-oriented environment with experienced colleagues and the opportunity to further develop your career in Talent Acquisition within a regulated setting.

Ready to grow with us?
Apply today and become part of Prothya.

Key Responsibilities

Engineering Execution & Project Delivery

• Translate strategic priorities into actionable engineering plans
• Lead and deliver engineering projects, modifications, and improvements
• Ensure delivery within scope, timelines, budgets, and quality standards
• Monitor progress, risks, and dependencies, and escalate where needed

Planning, Capacity & Prioritization

• Develop short- and mid-term engineering capacity plans
• Align planning with Operations, Automation, Validation, and Maintenance
• Support prioritization decisions at Technical Operations level

Technical Quality & Compliance

• Ensure compliance with GMP and internal standards
• Safeguard quality in documentation, change control, and project delivery
• Collaborate closely with Validation, Quality, and Automation teams

Financial & Cost Control

• Manage engineering budgets and project costs
• Support forecasting and cost estimation
• Identify and mitigate financial risks

Continuous Improvement

• Drive improvements in engineering processes and ways of working
• Promote knowledge sharing and standardization
• Identify optimization opportunities based on project learnings

Leadership

• Lead, coach, and develop a team of Senior Project Engineers and Project Managers
• Ensure clear roles, responsibilities, and workload balance
• Translate business objectives into team goals and deliver results
• Build a positive, performance-driven team culture

Stakeholder Management

• Act as the primary engineering contact for key stakeholders
• Ensure clear communication on scope, timelines, risks, and dependencies
• Enable effective cross-functional collaboration

EHS (Environment, Health & Safety)

• Ensure safe and compliant working practices
• Implement procedures to mitigate EHS risks
• Promote awareness and adherence within the team

GxP Responsibility

• Strong understanding of GxP requirements within your field
• Ensure compliance in engineering activities, documentation, and change control
• Contribute to SOP development and manage deviations where applicable

Your Profile

Education & Knowledge

• Academic degree in Chemistry, Pharmacy, Biology, Process Technology, or similar

Experience

• Proven experience leading large-scale engineering projects
• Solid knowledge of project management methodologies (e.g., PMI)
• Multiple years of experience in the pharmaceutical industry
• Demonstrated people management experience

Skills

• Strong leadership and organizational skills
• Excellent stakeholder management and communication abilities
• Structured, result-driven, and quality-focused mindset
• Ability to operate in a complex, regulated environment

Our offer

• A fulltime employment of 40 hours per week
• A market-rate salary
• A budget of 16,66% (holiday allowance and year-end bonus) of your gross salary, yours to spend or to save monthly
• A personal training budget of €2,100 every three years to foster professional growth and development.
• Flexible working hours after deliberation
• Your own place in a close-knit and expert team with an employer that stimulates growth and personal development
• Contribution to travel expenses from the first kilometer
• Excellent accessibility by public transport and private parking available.
• Sound pension provision.

The Position:

This is a high-impact role for a hands-on Financial Country Manager to lead the finance department for Prothya Netherlands. Reporting directly to the Corporate Controller, you will take full ownership of the NL entity’s financial health, ensuring the accuracy of the P&L and Balance Sheet.

You will lead a team of 3 AP clerks and serve as the primary point of contact for external auditors.

Your mission is to transition the department into a high-performance unit that supports our growth following the Intas acquisition.

Key Responsibilities:

• Closing & Reporting: Drive the month-end and year-end closing process for Prothya NL. Prepare high-quality financial statements in accordance with Dutch GAAP and IFRS for group reporting.
• Audit Management: Take the lead in the annual audit process. Prepare the year-end audit file, manage auditor requests, and ensure timely filing of statutory accounts.
• Manufacturing & Inventory: Perform deep-dive inventory analysis, reconcile stock movements, and provide insights into production variances and COGS.
• Internal Controls & Tax: Maintain the General Ledger, ensure tax compliance (VAT/CIT), and strengthen the internal control framework (SOX/Management Testing).
• Business Partnership: Work closely with FP&A to explain budget deviations and provide ad-hoc financial analysis to support strategic decision-making.

Candidate Profile:

• We are looking for an accomplished finance professional with a strong sense of ownership and the ability to thrive in a complex, fast-paced manufacturing environment.
• You should be a self-starter who can navigate technical accounting challenges while effectively managing a team.
• Requirements:
• Education: Master’s degree (WO) in Accounting, Finance, or Business Economics. (RA/RC designation is a significant plus).
• Experience: Minimum 5 years of relevant experience in financial control or senior accounting roles.
• Technical Skills: Comprehensive knowledge of Dutch GAAP is essential; familiarity with IFRS and/or Ind AS is a significant advantage.
• Industry: Proven experience in Manufacturing, Pharma, or Life Sciences with a focus on inventory and supply chain accounting.
• Leadership: Experience in managing or supervising small teams and leading external audit processes.
• Systems: Advanced Excel skills and experience with ERP systems (SAP experience is highly preferred).
• Languages: Full professional proficiency in both English and Dutch is mandatory.

GMP roles and responsibilities

• Management of EM UM sample staff and EM UM Officers including completion of performance feedback, reviews and disciplinary action.
• Ensure sampling and reporting is initiated and performed in a timely manner and adhering to quality standards.
• Draft and edit SOPs as needed.
• Responsible for insuring completion of required instrumentation maintenance and calibration.
• Collaborate with cross-functional teams, including Quality Assurance, Manufacturing, Product Support and Production to support product release and investigations.
• Assist in the development, optimization, and validation of EM UM methods and procedures to ensure robustness, accuracy and reproducibility.
• Takes GxP requirements into account during preparation, execution and reporting of GxP activities. Is fully aware of key standard operating procedures such as procedures for events, out of specifications and good documentation practice and applicable ISO/EP standards.
• Review of paperwork for compliance.
• Strong understanding of trending and microbiological troubleshooting.
• Participate in continuous improvement of the department and site as a whole; record keeping, EM UM processes, site safety, etc.
• Conduct periodic work meetings with the employees of the department and hold them accountable for results.
• Resolution of technical problems in accordance with policies and procedures.
• Providing orientation and training of testing personnel.

Your profile

• Bachelor education or working knowledge at Bachelor level in the field of pharmacy, microbiology or (bio)chemistry
• >5 years of experience within EM among which at least 3 years of people leadership experience and performance management
• Experienced with monthly and quartely reporting
• Strong affinity with manufacturing
• Knowledge of GMP guidelines with regard to quality control and validation
• Developments in the field should be followed and explored for consequences and/or usefulness for QC
• Conversational Dutch and excellent English language skills.

Our offer:

• Employment for 40 hours per week (less can be discussed).
• 8.33% end-of-year bonus and 8.33% holiday allowance.
• A personal training budget of €2,100 every three years to foster professional growth and development.
• Contribution to travel expenses from the first kilometer.
• Excellent accessibility by public transport and private parking available.
• A pension plan with Zorg & Welzijn, providing security for your future.
• A dynamic, safe, and challenging working environment with ample opportunities to grow, innovate, and learn, all while making a meaningful impact on the health of millions.

Key Responsibilities

Facility Management:

• Manage and process facility requests via Prothya’s Facility management system
• Act as the primary point of contact for facility-related queries, including those involving external parties
• Assist with day-to-day operations to ensure efficient and effective facility management.
• Oversee the implementation and administration of the access control system.
• Collaborate with external parties to maintain cleanliness and safety across the buildings and on-site grounds.
• Coordinate waste management processes to ensure compliance with policies.
• Provide necessary employee amenities, such as coffee, fruit, safety clothing, and access passes.
• Communicate facility-related information to staff (e.g., new policies, ongoing work).
• Coordinate cleaning activities outside of cleanroom.

Contract Management:

• Monitor and ensure the proper execution of service contracts related to facility management, including those for cleaning, work clothing, coffee, etc.

Requisition-to-Pay Process:

• Purchase and coordinate facility services by creating purchase orders, following up on orders, and confirming goods receipt.
• Monitor and approve external vendor time registrations.

Access Control and Policy:

• Oversee access control procedures and ensure compliance with policies.
• Issue access passes and ensure enforcement of access control policies.
• Administer the access control system, including managing profiles.

Administration:

• Manage administrative tasks related to facility services.
• Respond to internal correspondence and prepare related materials.
• Maintain accurate and up-to-date facility records and archive data.

Building Maintenance:

• Implement building management policies and procedures.
• Stay informed on the condition of the building (e.g., elevators, roofs, fire safety), and initiate necessary actions based on inspection reports.
• Supervise office relocations and external contractors working on facility-related tasks.

Your Qualifications

• Proven experience in facilities coordination or management.
• Strong organizational skills with a keen attention to detail.
• Self-starting mentality
• Ability to lead a small team (2 employees) and work independently.
• Familiarity with contract management and vendor relations.
• Knowledge of access control systems and facility management practices.
• Excellent communication skills, with the ability to work effectively across various departments.
• Good knowledge of Dutch and communicative in English

What do we offer?

• Employment for 40 hours per week.
• 8.33% end-of-year bonus and 8.33% holiday allowance.
• A personal training budget of €2,100 every three years to foster professional growth and development.
• Contribution to travel expenses from the first kilometer.
• Excellent accessibility by public transport and private parking available.
• A pension plan with Zorg & Welzijn, providing security for your future.
• A dynamic, safe, and challenging working environment with ample opportunities to grow, innovate, and learn, all while making a meaningful impact on the health of millions.

Doel van de functie

• Je gaat leidinggeven aan een team van operators verantwoordelijk voor het afvullen van gefabriceerde bloedplasma (tussen)producten;
• Je zorgt voor kennisoverdracht aan collega’s en medewerkers door onder andere het geven van presentaties, het (doen) verzorgen van trainingen en het inwerken van nieuwe gebruikers;
• Je adviseert de leidinggevende productiemanager over mogelijke modificaties in en verbeteringen van het proces in het betreffende aandachtsgebied;
• Je doet de ‘troubleshooting’ bij problemen en overlegt daarover met derden;
• Je voert controles uit op producten, processen en (hulp)materialen, onder andere door bemonstering en schouwing;
• Schrijft validatie- en kalibratieprotocollen en kwaliteitsdocumenten.

Jouw profiel

• Hbo werk -en denkniveau;
• >3 jaar ervaring in een leidinggevende functie binnen een GMP productieomgeving;
• Bij voorkeur kennis en ervaring in werken in geconditioneerde ruimtes en aseptisch afvullen;
• Extra vakkennis over het beheer van specialistisch productieprocessen;
• Kennis van vigerende kwaliteitssystemen, richtlijnen en procedures;
• Verhoogt eigen kennisniveau door actieve deelname aan cursussen en bijscholingsprogramma’s;
• Bereidheid tot werken in ploegendienst (ochtend en avond);
• Goede beheersing van de Nederlandse en Engelse taal.

Ons aanbod

• Een fulltime dienstverband (40 uur) met marktconform salaris
• Een totaal roostertoeslag van 14,83%
• 30 vakantiedagen
• 8,33% eindejaarsuitkering en 8,33% vakantietoeslag
• Persoonlijk opleidingsbudget van €2.100 per 3 jaar
• Tegemoetkoming in de reiskosten vanaf de eerste kilometer (0,23 cent per km met een max van 30 km)
• Goede bereikbaarheid met openbaar vervoer en eigen parkeergelegenheid
• Pensioenplan bij PFZW

The primary purpose of the Senior Project Engineer role is to manage and/or actively participate in engineering projects, while leading or advising on technical matters and ensuring that all activities are conducted in compliance with Good Manufacturing Practices (GMP).

This position involves planning, executing, and successfully closing projects related to both drug substance and drug product manufacturing. The focus is on improving operational efficiency, ensuring the highest quality standards, and maintaining a safe working environment.

1. General information

• Job Project Lead Engineering
• Reports to Manager Engineering
• Unit & Department Engineering / Engineering NL
• Site Amsterdam

Purpose of the job

The primary purpose of the job of a project lead engineering is leading engineering projects from start to finish, ensuring that all activities are conducted in compliance with Good Manufacturing Practices (GMP). The role involves planning, executing, and closing projects that relate to both drug substance and drug product manufacturing, with a focus on improving efficiency, ensuring quality, and maintaining safety standards.

2. Main Responsibilities & Accountabilities

• Key activities
• GMP roles and responsibilities

1. Project lead:

• Lead multiple large engineering projects from concept to completion, including project planning, budgeting, scheduling, and execution.
• Some projects will include internal project teams of several people, other projects will have to be executed mostly independently while relying more on external companies.
• Project examples include cleanroom reconstructions, capacity increases, efficiency gains, tech transfers and other large multidisciplinary engineering projects

2. GMP Compliance:

• Ensure all engineering activities comply with GMP, FDA, EMA, and other relevant regulatory requirements.
• Maintain comprehensive documentation for all projects to ensure traceability and compliance during audits and inspections.

3. Technical Leadership:

• Provide expert technical input on the design, installation, and qualification of new equipment and systems to ensure they meet GMP and Good Engineering standards.
• Independently write and/or review GMP documentation, such as change controls and qualification documents

4. Stakeholder and vendor management:

• Communicate project status, risks, and issues to stakeholders, including senior management, and clients.
• Facilitate effective communication and collaboration between various departments, including production, quality assurance, and regulatory affairs.
• Prepare and present detailed reports and project updates to stakeholders.
• Oversee activities performed by with vendors and contractors involved in engineering projects.
• Communicate and negotiate with vendors that deliver parts of the project.

Your profile

• Master’s/Bachelor degree in Engineering, or a related field.
• 8+ years of pharma experience, incl. 4+ years in strategic project management
• Certified in project management (e.g., Prince2 Practitioner, PMI PMP)

Our offer

• A fulltime employment of 40 hours per week
• A market-rate salary
• A budget of 16,66% (holiday allowance and year-end bonus) of your gross salary, yours to spend or to save monthly
• A personal training budget of €2,100 every three years to foster professional growth and development.
• Flexible working hours after deliberation
• Your own place in a close-knit and expert team with an employer that stimulates growth and personal development
• Contribution to travel expenses from the first kilometer
• Excellent accessibility by public transport and private parking available.
• Sound pension provision.

GMP roles and responsibilities:
Performing production operations

• Performs production operations on some processes using SOPs and regulations;
• Performs arithmetic operations for the purpose of dilutions and interprets their results;
• Provides preparations for the production process;
• Accounts for the performance of all work in logs and protocols;
• Administers raw and auxiliary materials in the information system.

Recording, administering and reporting deviations in the production process

• Identifies, records and reports deviations in prescribed operating procedures to the senior operator or supervisor;
• Performs administrative processing of rejected materials.

Performing work for the purpose of quality

• Performs checks on products, processes and (auxiliary) materials, including by sampling and inspection;
• Delivers samples for inspection at the designated location;
• Records quality control results in the information system;
• Routinely performs validation and calibration work for quality control purposes in accordance with regulations;
• Reviews and interprets results;
• Reports deviations to supervisor;
• Records quality control results in the information system;
• Writes standard validation and calibration reports and modifies SOPs as needed.

Performing workplace management

• Cleans used equipment and materials;
• Performs minor (technical) maintenance on equipment, fixes malfunctions of a simple nature, reports malfunctions to the supervisor, has contact with internal or external experts/technicians when necessary and supervises them in handling malfunctions;
• Maintains inventory and ensures timely replenishment.

Your profile:

• MBO eduation in a relevant discipline or equivalent level gained through experience
• Work or internship experience in a similar function within a GMP controlled environment
• Pharmaceutical process experience
• Detail-oriented, structured, proactive, and a strong team player
• Fluent in English and (preferred) Dutch
• Willing to work in 3 shifts (morning/ evening/ night) and during the weekends

What do we offer?

• Full-time employment (36h) with a competitive salary.
• Total shift allowance of 30,89%.
• 8.33% end-of-year bonus and 8.33% holiday allowance.
• A personal training budget of €2,100 every three years to foster professional growth and development.
• Contribution to travel expenses from the first kilometer.
• Excellent accessibility by public transport and private parking available.
• A pension plan with Zorg & Welzijn, providing security for your future.
• A dynamic, safe, and challenging working environment with ample opportunities to grow, innovate, and learn, all while making a meaningful impact on the health of millions.

The Position:

This is a high-impact role for a hands-on Financial Controller to lead the finance department for Prothya Netherlands. Reporting directly to the Corporate Controller, you will take full ownership of the NL entity’s financial health, ensuring the accuracy of the P&L and Balance Sheet.

You will lead a team of 3 AP clerks and serve as the primary point of contact for external auditors.

Your mission is to transition the department into a high-performance unit that supports our growth following the Intas acquisition.

Key Responsibilities:

• · Closing & Reporting: Drive the month-end and year-end closing process for Prothya NL. Prepare high-quality financial statements in accordance with Dutch GAAP and IFRS for group reporting.
• · Audit Management: Take the lead in the annual audit process. Prepare the year-end audit file, manage auditor requests, and ensure timely filing of statutory accounts.
• · Manufacturing & Inventory: Perform deep-dive inventory analysis, reconcile stock movements, and provide insights into production variances and COGS.
• · Internal Controls & Tax: Maintain the General Ledger, ensure tax compliance (VAT/CIT), and strengthen the internal control framework (SOX/Management Testing).
• · Business Partnership: Work closely with FP&A to explain budget deviations and provide ad-hoc financial analysis to support strategic decision-making.

Candidate Profile:

• We are looking for an accomplished finance professional with a strong sense of ownership and the ability to thrive in a complex, fast-paced manufacturing environment.
• You should be a self-starter who can navigate technical accounting challenges while effectively managing a team.
• Requirements:
• · Education: Master’s degree (WO) in Accounting, Finance, or Business Economics. (RA/RC designation is a significant plus).
• · Experience: Minimum 5–7 years of relevant experience in financial control or senior accounting roles.
• · Technical Skills: Comprehensive knowledge of Dutch GAAP is essential; familiarity with IFRS and/or Ind AS is a significant advantage.
• · Industry: Proven experience in Manufacturing, Pharma, or Life Sciences with a focus on inventory and supply chain accounting.
• · Leadership: Experience in managing or supervising small teams and leading external audit processes.
• · Systems: Advanced Excel skills and experience with ERP systems (SAP experience is highly preferred).
• · Languages: Full professional proficiency in both English and Dutch is mandatory.

Main Responsibilities & Accountabilities:

• Perform routine and non-routine microbiological testing of raw materials, in-process samples and finished products samples using approved test methods and protocols.
• Document all microbiological test activities, including test results, observations, deviations, and corrective actions in compliance with Good Documentation Practices (GDP) and GMP regulations.
• Interpret microbiological data and results, promptly reporting any deviations or out-of-specification (OOS) findings to management and assist in investigations and root cause analyses as needed.
• Participate in the qualification, calibration and maintenance of microbiological test equipment and instrumentation, ensuring accuracy, reliability and compliance with regulatory standards.
• Collaborate with cross-functional teams, including Quality Assurance, Manufacturing, Product Support and Production, to support product release and investigations.
• Assist in the development, optimization and validation of microbiological test methods and procedures to ensure robustness, accuracy and reproducibility.
• Takes GxP requirements into account during preparation, execution and reporting of GxP activities. Is fully aware of key standard operating procedures such as procedures for events, out of specifications and good documentation practice. Follows mandatory GxP training and maintains an appropriate training record. Identifies and escalates GxP issues.
• Assist in the investigation and resolution of laboratory deviations, non- conformances and customer complaints, following established Corrective and Preventive Action (CAPA) procedures.
• Strong understanding of trending and microbiological troubleshooting.
• Entails meticulous planning of laboratory activities, ensuring samples are processed within due timelines and providing oversight of lab operations.
• Provide technical guidance, training and support to junior technicians and laboratory staff.
• Assist the supervisor in daily operations, including scheduling, resource allocation and performance evaluation.
• Stay updated on industry trends, developments and best practices in microbiological and pharmaceutical sciences.

Your profile:

• Educational Background: A MLO or Bachelor’s degree in Microbiology, Biology, or a related field.
• Experience: At least 5 years of experience in a QC microbiology environment within the pharmaceutical or biotechnology industry.
• Knowledge: Strong understanding of microbiological testing methods, GMP, and GDP regulations.
• Attention to Detail: Meticulous documentation skills and a strong commitment to accuracy.
• Problem-solving Skills: Ability to analyse deviations, troubleshoot issues, and propose solutions.
• Leadership Qualities: Experience in mentoring or guiding junior lab staff is a plus.
• Fluency in both Dutch and English
• Ability to work in consignment service

What do we offer?

• Employment for 40 hours per week (less can be discussed).
• 8.33% end-of-year bonus and 8.33% holiday allowance.
• A personal training budget of €2,100 every three years to foster professional growth and development.
• Contribution to travel expenses from the first kilometer.
• Excellent accessibility by public transport and private parking available.
• A pension plan with Zorg & Welzijn, providing security for your future.
• A dynamic, safe, and challenging working environment with ample opportunities to grow, innovate, and learn, all while making a meaningful impact on the health of millions.

Key responsibilities:

• Perform routine and non-routine chemical analyses and microbiological testing of raw materials, in-process samples and finished products samples using approved test methods and protocols.
• Document all laboratory testing activities, including test results, observations, deviations, and corrective actions, in compliance with Good Documentation Practices (GDP) and GMP regulations.
• Interpret data and results, promptly reporting any deviations or out-of-specification (OOS) findings to management and assist in investigations and root cause analyses as needed.
• Participate in the qualification, calibration and maintenance of QC laboratory testing equipment and instrumentation, ensuring accuracy, reliability, and compliance with regulatory standards.
• Collaborate with cross-functional teams, including Quality Assurance, Manufacturing, Product Support and Production, to support product release and investigations.
• Assist in the development, optimization and validation of QC laboratory testing, methods and procedures to ensure robustness, accuracy and reproducibility.
• Takes GxP requirements into account during preparation, execution and reporting of GxP activities. Is fully aware of key standard operating procedures such as procedures for events, out of specifications and good documentation practice. Follows mandatory GxP training and maintains an appropriate training record. Identifies and escalates GxP issues.
• Assist in the investigation and resolution of laboratory deviations, nonconformances and customer complaints, following established Corrective and Preventive Action (CAPA) procedures.
• Receive and log incoming samples, verifying documentation for accuracy and completeness.

Your profile:

• MLO or Bachelor’s degree in microbiology, analytical chemistry, pharmaceutical sciences, or a related field.
• >3 years of experience working in a pharmaceutical laboratory, preferably in a GMP-regulated environment.
• Knowledge of microbiological and chemical testing techniques
• Proficiency in data analysis and interpretation using laboratory software applications (e.g., SAP and Empower).
• Excellent attention to detail, organizational skills, and ability to work effectively in a regulated environment.
• Strong communication skills and ability to collaborate with cross-functional teams.
• High level of independence is required when carrying out work according to guidelines, procedures and protocols.
• Perseverance and patience are required during routine analysis and the collection of data for deviations.
• Accurate, structured, flexible, and quality and safety conscious.
• You can work under time pressure, and you can organize and plan your work independently.
• Fluency in Dutch, and at least a good understanding of English.
• Ability to work in consignment service

What do we offer?

• Employment for 40 hours per week (less can be discussed).
• 8.33% end-of-year bonus and 8.33% holiday allowance.
• A personal training budget of €2,100 every three years to foster professional growth and development.
• Contribution to travel expenses from the first kilometer.
• Excellent accessibility by public transport and private parking available.
• A pension plan with Zorg & Welzijn, providing security for your future.
• A dynamic, safe, and challenging working environment with ample opportunities to grow, innovate, and learn, all while making a meaningful impact on the health of millions.

About the Role

As Operator B you are carrying out pharmaceutical production activities under quality conditions with blood plasma and (intermediate) products manufactured from it, including a number of production operations that are different in nature, often recurring daily on several production lines.

GMP roles and responsibilities

1. Performing production operations

– Performs production operations on some processes using SOPs and regulations;

– Performs arithmetic operations for the purpose of dilutions and interprets their results;

– Provides preparations for the production process;

– Accounts for the performance of all work in logs and protocols;

– Administers raw and auxiliary materials in the information system.

Deliverable:

Properly prepared and carried out as prescribed, controlled and responsible pharmaceutical manufacturing operations, even if a deviation occurred during preparation.

2. Recording, administering and reporting deviations in the production process

– Identifies, records and reports deviations in prescribed operating procedures to the senior operator or supervisor;

– Performs administrative processing of rejected materials.

Deliverable:

Discrepancies found, recorded and passed on as directed; records of rejected goods in order

3. Performing work for the purpose of quality

– Performs checks on products, processes and (auxiliary) materials, including by sampling and inspection;

– Delivers samples for inspection at the designated location;

– Routinely performs validation and calibration work for quality control purposes in accordance with regulations;

– Reviews and interprets results;

– Reports deviations to supervisor;

– Records quality control results in the information system;

– Writes standard validation and calibration reports and modifies SOPs as needed.

Deliverable:

Performed quality controls such that quality and safety of the product within the relevant production step is ensured. Contributed to quality assurance through up-to-date quality documents and validated calibrated equipment

4. Performing workplace management

– Cleans used equipment and materials;

– performs minor (technical) maintenance on equipment, fixes malfunctions of a simple nature, reports malfunctions to the supervisor, has contact with internal or external experts/technicians when necessary and supervises them in handling malfunctions;

– Maintains inventory and ensures timely replenishment.

Deliverable:

Hygienically maintained workplace; stock maintained such that work can continue

5. Performing all other duties incidental to the duties of the position

Qualifications

• MBO / Bachelor education in a relevant discipline or equivalent level gained through experience
• 1 year experience in a similar function within a GMP controlled environment
• Strong pharmaceutical packaging process experience
• Detail-oriented, structured, proactive, and a strong team player
• Fluent in Dutch and English
• Willing to work in shifts

We Offer:

• Full-time employment (36h) with a competitive salary.
• Total shift allowance following AVR.
• 8.33% end-of-year bonus and 8.33% holiday allowance.
• A personal training budget of €2,100 every three years to foster professional growth and development.
• Contribution to travel expenses from the first kilometer.
• Excellent accessibility by public transport and private parking available.
• A pension plan with Zorg & Welzijn, providing security for your future.
• A dynamic, safe, and challenging working environment with ample opportunities to grow, innovate, and learn, all while making a meaningful impact on the health of millions.

Key responsibilities:

• Receive samples of products made from plasma, check samples for integrity, register samples in the laboratory management system and store them at the correct temperature;
• Perform analyzes appropriate to the area of interest and manage the necessary techniques to carry out these analyzes expertly (including aseptic operations or quantitative determinations in chemistry);
• Take samples of incoming goods, products manufactured from plasma, also in classified GMP area (sample booth);
• Test the results against criteria and regulations;
• Send samples to external laboratories;
• Proper handling of laboratory equipment and performing calibration.

Your profile:

• Secondary laboratory education, (K)MLO or related.
• Experience working in a pharmaceutical or chemical laboratory. This position is open for MLO and Bachelor graduates with relevant internship experience as well.
• Preferably has knowledge of sampling, simple chemical tests.
• Experience working according to GMP/GLP or other quality standards.
• Attention to detail, organizational skills, and ability to work effectively in a regulated environment.
• Strong communication skills and ability to collaborate with cross-functional teams.
• High level of independence is required when carrying out work according to guidelines, procedures and protocols.
• Accurate, structured, flexible, and quality and safety conscious.
• Good command of the English language is required, and at least a basic understanding of Dutch.

What do we offer?

• Employment for 40 hours per week (less can be discussed).
• 8.33% end-of-year bonus and 8.33% holiday allowance.
• A personal training budget of €2,100 every three years to foster professional growth and development.
• Contribution to travel expenses from the first kilometer.
• Excellent accessibility by public transport and private parking available.
• A pension plan with Zorg & Welzijn, providing security for your future.
• A dynamic, safe, and challenging working environment with ample opportunities to grow, innovate, and learn, all while making a meaningful impact on the health of millions.

Key responsibilities:

• Perform routine and non-routine chemical testing of raw materials, in-process samples and finished products samples using approved test methods and protocols.
• Document all chemical testing activities, including test results, observations, deviations, and corrective actions, in compliance with Good Documentation Practices (GDP) and GMP regulations.
• Interpret chemical data and results, promptly reporting any deviations or out-of-specification (OOS) findings to management and assist in investigations and root cause analyses as needed.
• Participate in the qualification, calibration, and maintenance of chemical testing equipment and instrumentation, ensuring accuracy, reliability, and compliance with regulatory standards.
• Collaborate with cross-functional teams, including Quality Assurance, Manufacturing, Product Support and Regulatory Affairs, to support product release, investigations, and regulatory submissions.
• Assist in the development, optimization, and validation of chemical testing methods and procedures to ensure robustness, accuracy, and reproducibility.
• Takes GxP requirements into account during preparation, execution and reporting of GxP activities. Is fully aware of key standard operating procedures such as procedures for events, out of specifications and good documentation practice. Follows mandatory GxP training and maintains an appropriate training record. Identifies and escalates GxP issues.
• Assist in the investigation and resolution of laboratory deviations, non-conformances, and customer complaints, following established Corrective and Preventive Action (CAPA) procedures.
• Entails meticulous planning of laboratory activities, ensuring samples are processed within due timelines, and providing oversight of lab operations.
• Provide technical guidance, training and support to junior technicians and laboratory staff.
• Assist the supervisor in daily operations, including scheduling and recruitment.
• Stay updated on industry trends, developments, and best practices in chemistry and pharmaceutical sciences.
• Adhere to environment health and safety policies and practices within QC.

Your profile:

• MLO or Bachelor’s degree in chemistry, pharmaceutical sciences, or a related field.
• >5 years of experience working in a pharmaceutical laboratory, preferably in a GMP-regulated environment.
• Strong knowledge of chemical testing techniques, including High-Performance Liquid Chromatography (HPLC), Gas Chromatography (GC), Ultraviolet-Visible (UV-Vis) spectroscopy, and Fourier Transform Infrared (FTIR) spectroscopy.
• Proficiency in data analysis and interpretation using laboratory software applications (e.g., SAP and Empower).
• Excellent attention to detail, organizational skills, and ability to work effectively in a regulated environment.
• Strong communication skills and ability to collaborate with cross-functional teams.
• High level of independence is required when carrying out work according to guidelines, procedures and protocols.
• Perseverance and patience are required during routine analysis and the collection of data for deviations.
• Accurate, structured, flexible, and quality and safety conscious.
• You are able to work under time pressure and you can organize and plan your work independently.
• Good command of the English language is required, and at least a basic understanding of Dutch.
• Hands-on problem-solving skills – translating your understanding of the problem into an approach towards a solution.

What do we offer?

• Employment for 40 hours per week (less can be discussed).
• 8.33% end-of-year bonus and 8.33% holiday allowance.
• A personal training budget of €2,100 every three years to foster professional growth and development.
• Contribution to travel expenses from the first kilometer.
• Excellent accessibility by public transport and private parking available.
• A pension plan with Zorg & Welzijn, providing security for your future.
• A dynamic, safe, and challenging working environment with ample opportunities to grow, innovate, and learn, all while making a meaningful impact on the health of millions.

The primary purpose of the job of a Validation Engineer is to ensure that all manufacturing processes, equipment, and associated systems are validated to meet strict regulatory and quality standards.The role involves developing validation strategies, leading validation activities, writing and reviewing validation documentation and resolving validation issues and deviations.

1. General information

Job (Senior) Validation Engineer

Reports to Manager Engineering

Unit & Department Engineering / Engineering NL

Site: Amsterdam

Main Responsibilities & Accountabilities

Key activities

GMP roles and responsibilities

1. Validation Strategy and Planning:

• Develop and manage the overall validation strategy for processes and equipment, ensuring it aligns with both GMP requirements and industry best practices. Plan and schedule validation activities to efficiently support manufacturing timelines and product launches.

2. Execution of Validation Activities:

• Lead the execution of validation studies, including equipment validation, cleaning validation, and computer system validation. This involves drafting validation protocols, executing tests, collecting data, and analyzing results.

3. Regulatory Compliance:

• Ensure that all validation activities comply with relevant regulatory standards such as FDA, EMA, and ICH guidelines, as well as specific GMP requirements. Stay updated on regulatory changes and adapt validation strategies accordingly.

4. Risk Management:

• Implement risk management strategies in validation processes. Identify potential risks associated with process and equipment operations and develop mitigation strategies to ensure continuous compliance and performance.

5. Vendor and Contractor Management:

• Oversee and manage relationships with vendors and contractors involved in the validation process.
• Ensure that all external partners comply with the same quality and regulatory standards as internal processes.

Your profile

• Bachelor degree in Automation Engineering, or a related field.
• At least 5 years of experience, pharma/GMP regulated environment. Strong background in either PLC, SCADA, DCS or MES and manager experience highly preferred

Our offer

• A fulltime employment of 40 hours per week
• A market-rate salary
• A budget of 16,66% (holiday allowance and year-end bonus) of your gross salary, yours to spend or to save monthly
• A personal training budget of €2,100 every three years to foster professional growth and development.
• Flexible working hours after deliberation
• Your own place in a close-knit and expert team with an employer that stimulates growth and personal development
• Contribution to travel expenses from the first kilometer
• Excellent accessibility by public transport and private parking available.
• Sound pension provision.

Werkzaamheden: 

• Je analyseert problemen, verhelpt storingen en voert onderhoud en modificaties uit aan mechanische- en elektrotechnische onderdelen in onze farmaceutische fabriek om de diverse productieprocessen optimaal te laten presteren.
• Je begeleidt en controleert de werkzaamheden externe bedrijven die onderhoudstaken aan de diverse installaties verrichten;
• Het uitvoeren van tank- en lasinspecties en NEN keuringen; hierin leiden we je natuurlijk op mocht je deze competenties niet hebben.
• Het verrichten van administratieve werkzaamheden behorende bij de functie: Werkvergunning, order/ticket afhandeling en urenregistratie.
• je geeft technisch advies op het specifieke vakgebied aan o.a. de projectafdeling, de eigen afdeling onderhoud en kalibratie en de interne klant.

Functie-eisen: 

• Afgeronde MBO-opleiding op het vakgebied van werktuigbouw en/of meet- en regeltechniek, bij voorkeur met specialisatie in mechatronica.
• Werkervaring op het gebied van werktuigbouw/mechatronica.
• Ervaring op het gebied van demonteren en monteren van appendages zoals (regel)kleppen, roerwerken, pompen, warmtewisselaars, condenspotten, etc.
• Ervaring op het gebied van TIG RVS lassen en machinebankwerken.
• Het is een pré als je werkervaring hebt gerelateerd aan procestechniek, petrochemie, in de voedings- en/of farmaceutische industrie. Bekend met de regels rondom GMP. Ervaring in machinebouw, koeltechniek, stroomtechniek en/of vacuümtechniek is wenselijk, evenals ervaring met PLC-, en meet- en regeltechniek en/of elektrisch schakelen.

Wat we verder van jou verwachten: 

• Je werkt nauwkeurig, gestructureerd en zelfstandig en vindt het leuk om met details bezig te zijn.
• Je bent klantgericht en collegiaal en ondersteunt collega’s buiten je eigen team.
• Je toont initiatief en reageert positief en proactief.
• Waar nodig ben je bereid tot het doorlopen van een uitgebreide inwerkperiode binnen Prothya.

Ons aanbod: 

• Een fulltime dienstverband (40 uur), part-time is bespreekbaar
• 30 vakantiedagen
• 8,33% eindejaarsuitkering en 8,33% vakantietoeslag
• Persoonlijk opleidingsbudget van €2.100 per 3 jaar
• Tegemoetkoming in de reiskosten vanaf de eerste kilometer (0,23 cent per km met een max van 30 km)
• Goede bereikbaarheid met openbaar vervoer en eigen parkeergelegenheid
• Pensioenplan bij PFZW

Key responsibilities

• Perform routine chemical testing of raw materials, in-process samples and finished products samples using approved test methods and protocols.
• Document all chemical testing activities, including test results, observations, deviations, and corrective actions, in compliance with Good Documentation Practices (GDP) and GMP regulations.
• Interpret chemical data and results, promptly reporting any deviations or out-of-specification (OOS) findings to management, and assist in investigations and root cause analyses as needed.
• Participate in the qualification, calibration, and maintenance of chemical testing equipment and instrumentation, ensuring accuracy, reliability, and compliance with regulatory standards.
• Collaborate with cross-functional teams, including Quality Assurance, Manufacturing, Product Support and Regulatory Affairs, to support product release, investigations, and regulatory submissions.
• Assist in the development, optimization, and validation of chemical testing methods and procedures to ensure robustness, accuracy, and reproducibility.
• Takes GxP requirements into account during preparation, execution and reporting of GxP activities. Is fully aware of key standard operating procedures such as procedures for events, out of specifications and good documentation practice. Follows mandatory GxP training and maintains an appropriate training record. Identifies and escalates GxP issues.
• Assist in the investigation and resolution of laboratory deviations, non-conformances, and customer complaints, following established Corrective and Preventive Action (CAPA) procedures.

Other responsibilities

• Legal compliance
  • Stay current on evolving legal requirements related to pharmaceutical manufacturing.
  • Ensure the organization’s compliance with applicable laws, regulations, and industry standards.
• Environmental health and safety (EHS) compliance
  • Adhere to EHS policies and practices within QC.
  • Adhere to all safety protocols and regulations in the laboratory environment, including proper handling, disposal, and containment of microbiological hazards and biohazardous waste.
  • Supports measures to ensure a safe and environmentally responsible workplace within QC.

Your profile

• Secondary laboratory education, (K)MLO or related.
• (internship) experience working in a pharmaceutical laboratory/ in a GMP-regulated environment is preferred.
• Knowledge of chemical testing techniques, spectroscopy, titrations and various assays.
• Proficiency in data analysis and interpretation using laboratory software applications (e.g., SAP).
• Excellent attention to detail, organizational skills, and ability to work effectively in a regulated environment.
• Strong communication skills and ability to collaborate with cross-functional teams.
• High level of independence is required when carrying out work according to guidelines, procedures and protocols.
• Perseverance and patience are required during routine analysis and the collection of data for deviations.
• Accurate, structured, flexible, and quality and safety conscious.
• You are able to work under time pressure and you can organize and plan your work independently.
• Hands-on problem solving skills – translating your understanding of the problem into an approach towards a solution.
• Good command of the English language is required, and at least a basic understanding of Dutch.

What We Offer

• A full-time position with a competitive salary.
• A budget of 16.66% (holiday allowance and year-end bonus) of your gross salary, which can be used monthly.
• Personal training budget of €2,100 every 3 years.
• Contribution to travel expenses from the first kilometer.
• Good accessibility by public transport, with private parking options available.
• Pension plan with Zorg & Welzijn.

Key Responsibilities

Utilities Monitoring & Testing

• Perform routine sampling and microbiological/chemical testing of utilities (HPW, WFI, clean steam, compressed air).
• Ensure sampling plans and test methods comply with GMP, SOPs, and regulatory guidelines.
• Operate and maintain laboratory equipment used for utilities testing.

Data Review & Trending

• Review and approve test results for accuracy and completeness.
• Perform data trending and identify deviations or out-of-specification (OOS) results.
• Escalate issues promptly and support investigations.

Compliance & Documentation

• Maintain accurate and complete documentation in accordance with GMP and company SOPs.
• Participate in internal and external audits, providing data and explanations as required.
• Ensure timely reporting and closure of deviations and CAPAs.

Continuous Improvement

• Contribute to risk assessments and contamination control strategies for utilities.
• Support validation and qualification activities for utility systems.
• Identify opportunities for process optimization and efficiency improvements.

Collaboration

• Work closely with Engineering, Production, and QA teams to ensure utility systems remain compliant.
• Provide technical support during investigations and audits.

Your profile

• Bachelor’s degree in Microbiology, Chemistry, Biotechnology, or related field.
• >3 years of work experience in QC utilities monitoring within pharmaceutical or biotech industry.
• Strong knowledge of GMP, EU Annex 1, ISO standards, and regulatory requirements.
• Familiarity with microbiological and chemical testing methods for utilities.
• Excellent attention to detail, organizational, and communication skills.
• Analytical thinking and problem-solving.
• Ability to work independently and in a team environment.
• Commitment to quality and continuous improvement.
• Fluency in English. A conversational level of Dutch is preferred.

What do we offer?

• Full-time employment (40h) with flexible working hours in consultation. Working part-time can be discussed.
• 8.33% end-of-year bonus and 8.33% holiday allowance.
• A personal training budget of €2,100 every three years to foster professional growth and development.
• Contribution to travel expenses from the first kilometer.
• Excellent accessibility by public transport and private parking available.
• A pension plan with Zorg & Welzijn, providing security for your future.
• A dynamic, safe, and challenging working environment with ample opportunities to grow, innovate, and learn, all while making a meaningful impact on the health of millions.

The Role:

As our Asset Engineer, you will be responsible for managing the technical assets of a production line, blending the roles of maintenance engineer and technical manager. Your goal is to maintain the overall health and functionality of the installation, from troubleshooting to planned maintenance.

Key Responsibilities:

• Oversee all technical operations for a production line, ensuring minimal downtime.
• Maintain strong relationships with key suppliers and support technical procurement negotiations.
• Advise on CAPEX projects and take a proactive role in asset management and lifecycle assessments.
• Manage all wear and tear activities, keeping everything running smoothly.
• Act as the liaison between maintenance and production teams, ensuring that all decisions align with the company’s strategic goals.

Specific tasks include:

• Monitoring asset performance, organising Root Cause Analyses (RCAs), and leading multifunctional teams to implement lasting solutions.
• Executing and optimizing preventive maintenance plans using a Computerized Maintenance Management System (CMMS).
• Ensuring the maintainability of new assets, overseeing the introduction of spare parts strategies, and implementing long-term maintenance plans.

What You’ll Bring:

• Proactive & Entrepreneurial mindset, with a sense of urgency.
• Strong communication skills and the ability to interact at all levels of the organisation.
• A solution-oriented approach, thriving in a dynamic environment where you need to think on your feet.

Your Background:

• Education: Bachelor in a technical field, with a preference for Project Management or Maintenance Technology.
• Experience: Minimum of 5 years in a similar role, with strong knowledge of SAP-PM and GxP regulations.
• Skills: Technically oriented, analytically strong, and fluent in both Dutch and English.

What we offer:

• Full-time employment (40h) with flexible working hours in consultation. Working part-time can be discussed.
• 8.33% end-of-year bonus and 8.33% holiday allowance.
• A personal training budget of €2,100 every three years to foster professional growth and development.
• Contribution to travel expenses from the first kilometer.
• Excellent accessibility by public transport and private parking available.
• A pension plan with Zorg & Welzijn, providing security for your future.
• A dynamic, safe, and challenging working environment with ample opportunities to grow, innovate, and learn, all while making a meaningful impact on the health of millions.

Belangrijkste verantwoordelijkheden

• Strategisch Kwaliteitsbeheer: Ontwikkelen en implementeren van een strategisch kwaliteitsbeleid dat bijdraagt aan de doelstellingen van Prothya. Je stelt prioriteiten en plant verbeterprojecten die compliance, efficiëntie en operationele excellentie bevorderen.
• Toezicht op QA en QC Activiteiten: Leiden van zowel QA als QC afdelingen met een sterke focus op compliance met GMP-richtlijnen. Je beheert en stuurt dagelijkse kwaliteitsactiviteiten, zorgt voor een optimale workflow en ondersteunt bij het oplossen van kwaliteitskwesties.
• Ontwikkelen van Processen en Structuren: Aansturen van het opzetten van effectieve kwaliteitsprocessen. Je leidt een team dat met beperkte automatisering werkt en zoekt actief naar oplossingen om de efficiëntie te verbeteren binnen een dynamische en soms uitdagende setting.
• Stakeholder en Team Management: Motiveren en coachen van een divers en groeiend team van QC- en QA-professionals. Je hebt een belangrijke rol in het behouden van een positieve werksfeer en het versterken van samenwerking tussen verschillende afdelingen en sites.
• Audits en Inspecties: Voorbereiden en begeleiden van interne en externe audits en zorgen dat de afdeling voldoet aan alle Europese en Amerikaanse kwaliteitsrichtlijnen (cGMP, ICH). Je bent verantwoordelijk voor het onderhouden van contacten met externe stakeholders en toezichthouders.

Specifieke uitdagingen

• In deze rol kom je enkele belangrijke uitdagingen tegen, waaronder:
• Teamontwikkeling en Zelfstandigheid: Het huidige team omvat zowel ervaren als junior medewerkers. Je ondersteunt hen in hun professionele ontwikkeling en moedigt zelfstandigheid aan, wat belangrijk is gezien de dynamische omgeving en de noodzaak voor hands-on leiderschap.
• Hands-on Mentaliteit: De situatie vereist een betrokken manager die regelmatig aanwezig is op de werkvloer en actief bijdraagt aan het oplossen van dagelijkse operationele uitdagingen.
• Efficiëntie en Procesoptimalisatie: Door een lage automatiseringsgraad vraagt deze rol om iemand die kan schakelen tussen compliance en pragmatische oplossingen om de productiviteit te verhogen.
• Balans tussen Compliance en Operational Excellence: Je bewaakt de naleving van strenge kwaliteitsnormen terwijl je tegelijkertijd zorgt voor werkbare, efficiënte processen.

Jouw profiel

• Je bent een strategische en resultaatgerichte leider met een scherp oog voor detail en ervaring binnen een sterk gereguleerde omgeving. Daarnaast beschik je over:
• Een academische opleiding in een relevant vakgebied zoals Chemie, Biotechnologie of Farmacie, bij voorkeur aangevuld met managementtraining.
• Minimaal 8-10 jaar ervaring binnen de farmaceutische of biotechnologische industrie, met aantoonbare expertise in kwaliteitsbeheer en productieprocessen.
• Uitgebreide kennis van GMP-richtlijnen en internationale kwaliteitsstandaarden; ervaring met Europese en Amerikaanse regelgeving (ICH, FDA) is essentieel.
• Uitstekende communicatieve vaardigheden in Nederlands en Engels, zowel schriftelijk als mondeling.
• Een hands-on mentaliteit, pragmatische aanpak en ervaring met het initiëren van veranderingstrajecten en procesoptimalisaties.
• Een sterk ontwikkeld analytisch vermogen en besluitvaardigheid, met ervaring in het succesvol aansturen en ontwikkelen van teams.

Wat biedt Prothya jou?

• Bij Prothya Biosolutions krijg je de kans om deel uit te maken van een gedreven team in een rol met directe impact op onze kwaliteitsnormen. Wij bieden:
• Een uitdagende en verantwoordelijke positie in een internationale en innovatieve organisatie.
• Een competitief salaris en uitstekende secundaire arbeidsvoorwaarden.
• Professionele ontwikkelingsmogelijkheden en trainingen om je carrière naar een hoger niveau te tillen.
• Een cultuur waarin respect, diversiteit en betrokkenheid centraal staan.

Key responsibilities:

Initial Qualification

• Project Leadership: Lead installation, qualification, and integration of new analytical instruments and computerized systems in QC laboratories and production, ensuring timely delivery and compliance.
• URS Development: Define and document User Requirement Specifications (URS) in collaboration with QC operations, aligning with regulatory, business, and technical needs.
• Regulatory Compliance: Ensure adherence to Data Integrity principles, 21 CFR Part 11, and Annex 11 requirements for computerized systems.
• Commissioning & Documentation: Coordinate commissioning tasks, maintain traceability, and ensure full documentation for audits and inspections.
• Qualification Protocols: Draft, review, and approve IQ/OQ/PQ protocols and reports in collaboration with QA and relevant stakeholders.
• Acquisition & Progress Monitoring: Manage acquisition and qualification activities, track progress in MasterControl or equivalent systems, and escalate risks proactively.
• SAP Ordering: Create purchase requisitions and manage ordering in SAP, ensuring timely procurement and budget compliance.
• Technical Support: Provide expertise for validation of analytical and microbiological methods, including troubleshooting during qualification phases.
• Process Optimization: Continuously improve qualification processes, SOPs, and templates to enhance efficiency and compliance.

Re-qualification, Calibration, and Maintenance

• Strategic Planning: Develop and implement annual plans for re-qualification and calibration, including resource allocation and vendor coordination.
• Execution & Oversight: Prepare, execute and manage re-qualification and calibration activities for QC and production instruments, ensuring minimal downtime.
• Procedure Management: Update SOP’s and work instructions to reflect evolving best practices and regulatory changes.
• Preventive Maintenance: Ensure timely preventive maintenance and repairs in collaboration with laboratories and external suppliers.
• Maintenance Contract Management: Manage yearly maintenance contracts with suppliers, including negotiation, renewal, and compliance with SLA’s.
• Supplier Relationship: Act as primary contact for suppliers regarding maintenance schedules, contract terms and performance monitoring.

Periodic Review of QC and Production Systems

• Compliance Monitoring: Prepare and maintain Periodic Review Reports for analytical instruments and computerized systems.
• Audit Trail Review: Conduct periodic reviews of audit trails, user access, and system compliance to maintain robust data integrity.

Retirement Phase

• Decommissioning: Coordinate and document decommissioning and Out-of-Use activities for obsolete systems, ensuring proper data migration and compliance with retention policies.

QC Alarm Management

• Incident Investigation: Investigate QC alarm reports for controlled temperature areas, perform root cause analysis and assess impact on product quality.
• Corrective Actions: Implement CAPAs and preventive measures to avoid recurrence.

Data Integrity Improvement Projects

• Risk Assessment: Perform detailed risk assessments to identify gaps in data integrity for analytical instruments and computerized systems.
• Remediation Planning: Define and implement remediation actions to close identified gaps, ensuring compliance with global data integrity standards.
• Cross-Functional Collaboration: Work closely with QC, Production QA, and IT teams to ensure timely execution of remediation plans.
• Documentation & Reporting: Maintain clear records of risk assessments, remediation actions, and progress tracking for audits and inspections.

Continuous Improvement

• Identify and implement process improvements to enhance efficiency, reduce compliance risk, and optimize lifecycle management.
• Drive digitalization initiatives and automation projects within QC and production, leveraging emerging technologies for smarter workflows.

Subject Matter Expert (SME)

• Act as SME during internal audits, regulatory inspections, and customer audits.
• Provide expert guidance on equipment qualification, computerized system validation and data integrity compliance.
• Train QC teams on validation principles and regulatory expectations.

Your profile:

• Bachelor or Master degree in Chemistry, Industrial Pharmacy, Biotechnology, or related field.
• Minimum 5 years of experience in QC and pharmaceutical manufacturing.
• Strong knowledge of analytical instruments and computerized systems.
• Strong knowledge of cGMP, Data Integrity and computerized system validation principles.
• Expertise in IQ/OQ/PQ protocols and validation principles.
• Expertise in equipment qualification, calibration strategies and lifecycle management.
• Proficiency in MasterControl, SAP, and MS Office tools; knowledge of Empower, SAP master data, or similar systems is a plus.
• Excellent project management, documentation and problem-solving skills.
• Strong analytical mindset with attention to detail and risk-based thinking.
• Experience with FDA, EMA, and ICH guidelines; familiarity with audit preparation and inspection readiness.
• Knowledge of lean principles and continuous improvement methodologies is an advantage.
• Ability to work cross-functionally and communicate effectively in English and preferably Dutch.

What We Offer:

• Full-time employment (40h) with flexible working hours in consultation.
• 8.33% end-of-year bonus and 8.33% holiday allowance.
• A personal training budget of €2,100 every three years to foster professional growth and development.
• Contribution to travel expenses from the first kilometer.
• Excellent accessibility by public transport and private parking available.
• A pension plan with Zorg & Welzijn, providing security for your future.
• A dynamic, safe, and challenging working environment with ample opportunities to grow, innovate, and learn, all while making a meaningful impact on the health of millions.

Key repsonsibilities:

Validation Strategy and Management:
Develop and maintain the validation strategy for computerized systems in line with GMP standards such as ISPE GAMP 5, 21 CFR Part 11, and Eudralex Volume 4 Annex 11. Ensure comprehensive management of validation activities to support regulatory compliance.

Execution of Validation Activities:
Execute validation processes, including planning, testing, and documenting validations for computerized systems to ensure they are fit for their intended use and comply with all relevant regulatory requirements.

Continuous Improvement of CSV Processes:
Continuously review and improve CSV processes and procedures to enhance their effectiveness and efficiency. Implement best practices to streamline validation activities and ensure ongoing compliance with GMP standards.

Leadership in CSV Activities:
Lead or consult on CSV activities within IT/OT automation projects and changes. Provide expert guidance to project teams, ensuring that all aspects of system validation meet quality and regulatory standards.

Cross-Functional Collaboration:
Collaborate with IT, Quality Assurance, Engineering, and other relevant departments to align validation activities with business and regulatory objectives. Facilitate communication and understanding across departments to ensure successful implementation of validation standards.

Documentation and Record Keeping:
Maintain meticulous records and documentation of validation activities, including validation plans, reports, and performance data. Ensure documentation is readily available and organized for audits and inspections.

Training and Mentoring:
Provide training and mentorship to team members and other staff on CSV principles, practices, and regulatory requirements. Develop training materials and conduct sessions to enhance the team’s competency in CSV.

Regulatory Awareness and Compliance:
Stay updated with changes in regulatory standards and guidelines affecting CSV. Implement necessary updates to validation processes to maintain compliance and address new regulatory challenges.

Risk Management:
Identify and mitigate risks associated with the validation of computerized systems. Employ risk management strategies during the validation lifecycle to prevent potential compliance issues.

Quality Assurance Collaboration:
Work closely with the Quality Assurance team to ensure that CSV practices adhere to quality standards and contribute to the overall quality goals of the organization.

Your profile

• A strong understanding of computer systems, software applications, and validation processes, as well as knowledge of relevant regulations such as GAMP5, 21 CFR Part 11, and EudraLex Volume 4 Annex 11.
• Experience in IT, automation or QC computerized systems.
• The ability to critically evaluate and interpret data, identify potential risks and non-compliance issues, and conduct gap analyses to ensure the effectiveness of the validation process.
• Strong knowledge of pharmaceutical manufacturing processes, quality systems, and regulatory requirements.
• Experience in developing and executing validation test plans, test scripts, and test cases.
• Excellent problem-solving, analytical, and risk-assessment skills.
• Experience within a GMP production environment.
• The ability to create and review validation documentation, ensuring accuracy, completeness, and compliance with regulatory requirements.

Our offer

•  A fulltime employment of 40 hours per week
• A market-rate salary
• A budget of 16,66% (holiday allowance and year-end bonus) of your gross salary, yours to spend or to save monthly
• A personal training budget of €2,100 every three years to foster professional growth and development.
• Flexible working hours after deliberation
• Your own place in a close-knit and expert team with an employer that stimulates growth and personal development
• Contribution to travel expenses from the first kilometer
• Excellent accessibility by public transport and private parking available.
• Sound pension provision.

GMP roles and responsibilities:

Managing part of the production process:

• Keeps knowledge up-to-date regarding the relevant part of the production process;
• Manages the control methodology and equipment associated with the relevant part of the production process;
• Advises the supervisor on possible modifications in and improvements of the process in the relevant part of the production;
• Does the “troubleshooting” for problems and consults with third parties about them;
• Establishes and leads projects in modifications and improvements after approval of the project plan;
• Reports project outcomes to supervisor;
• Performs administration and correspondence required for the production process.

Deliverable: Up-to-date knowledge of the relevant part of the production process, knowledge shared with employees; well-functioning production process and equipment

Performing production operations:

• Performs production operations according to SOPs and regulations;
• Performs arithmetic operations for the purpose of dilutions, among other things;
• Provides preparations for production process, cleans used equipment and materials after completion;
• Accounts for the performance of all work in logs and protocols;
• Identifies, records and reports deviations in prescribed operating procedure to supervisor;
• Administers raw and auxiliary materials in the information system and performs administrative processing of rejected materials;
• Performs minor (technical) maintenance on equipment, fixes malfunctions of a simple nature, reports malfunctions to the supervisor, has contact with internal or external experts/technicians when necessary and supervises them in handling malfunctions;
• Maintains inventory and ensures timely replenishment.

Training employees and ensuring compliance with quality standards:

• Ensures employees are adequately trained and inducted and coordinates employee requalification;
• Instructs employees on modified and new regulations and supervises their introduction;
• Ensures correctly and uniformly completed logbooks, batch files, etc. and addresses employees accordingly.
• Ensures that preparation is done only using authorized protocols and regulations and that deviations from authorized regulations/protocols are properly documented;
• Ensures that routine rehabilitation planning is performed and submits the results to the Head for authorization.

Result to be achieved: Employees instructed and trained such that they are able to perform their work independently in accordance with applicable procedures

Monitoring quality and quality systems:

• Writes validation and calibration protocols and quality documents;
• Performs checks on products, processes and (auxiliary) materials, including by sampling and inspection;
• Delivers samples for inspection at the designated location;
• Initiates and performs work on behalf of validation and calibration activities for own and other departments. Records the results of quality controls in the information system and writes reports;
• Adjusts regulations/protocols in response to audit findings; makes suggestions to keep existing regulations and protocols current and improved;
• Monitors water for injection (WFI) and work areas to be used;
• Identifies and processes discrepancies and Alertboard issues;
• Resolves internal complaints;
• Implements quality systems on the shop floor in coordination with the Head and QA;
• Participates in the preparation and implementation of new processes.

Result to be achieved: Monitored quality and quality systems such that preparations could be carried out in accordance with applicable guidelines and worked on continuous quality improvement

Operationally managing a team of employees:

• Sets work schedule for the team and coordinates work;
• Conducts work meetings with, motivates and coaches the team;
• Assesses the quality of work and, if necessary, addresses employees accordingly;
• Provides data to supervisor regarding employee performance;
• Reports to supervisor.

Deliverable: work organized in such a way that the team of employees is motivated and enthusiastic; work according to schedule and quality

Your profile:

• Bachelor eduation in a relevant discipline or equivalent level gained through experience
• >5 years experience in a similar function within a GMP controlled environment
• Strong pharmaceutical packaging process experience
• Detail-oriented, structured, proactive, and a strong team player
• Fluent in Dutch and English
• Willing to work in 2 shifts (morning/ evening)

What we offer:

• Full-time employment (40h) with a competitive salary.
• Total shift allowance of 14,83%.
• 8.33% end-of-year bonus and 8.33% holiday allowance.
• A personal training budget of €2,100 every three years to foster professional growth and development.
• Contribution to travel expenses from the first kilometer.
• Excellent accessibility by public transport and private parking available.
• A pension plan with Zorg & Welzijn, providing security for your future.
• A dynamic, safe, and challenging working environment with ample opportunities to grow, innovate, and learn, all while making a meaningful impact on the health of millions.

Lead and develop the automation team

Overview

Provide direction, coaching, and performance management for a team of automation professionals, fostering a culture of ownership, technical excellence, and continuous improvement.

The automation team consists of 5 technicians (who rotate 1 week per 5 weeks on standby duty to support production outside working ours), 1 CSV specialist and 1 automation engineer

Detailed tasks

• Set team priorities, allocate resources, and manage workload across maintenance, troubleshooting, and project activities.
• Develop competencies within the team through training and mentoring.
• Define clear roles, responsibilities, and performance objectives.
• Promote cross-functional collaboration with Engineering, IT, Validation, and Manufacturing.

Ensure Reliable Operation and Maintenance of Automation Systems

Overview

Oversee the preventive and corrective maintenance, troubleshooting, and lifecycle management of all site automation systems, ensuring reliability and data integrity in a GMP environment.

Detailed tasks

• Ensure timely response and resolution of automation-related breakdowns and deviations.
• Maintain system documentation (architecture, configuration, change records) in compliance with GMP.
• Plan and oversee execution of preventive maintenance and periodic reviews.
• Coordinate with IT on infrastructure reliability, cybersecurity, and virtualization platforms supporting automation systems.

Drive Continuous Improvement and Project Execution

Overview

Lead or support automation projects, system upgrades, and digitalization initiatives that improve performance, compliance, and efficiency of manufacturing operations.

Come up with medium- and long-term automation strategy, with a high degree of ownership. Get cross-functional buy-in, divide into actionable projects and drive them to completion with continuous communication and escalation where needed.

Detailed tasks

• Identify and implement improvements to automation systems, user interfaces, and data collection.
• Support or lead automation scope in capital projects (URS, design review, FAT/SAT, IOPQ).
• Collaborate with Engineering and Manufacturing on new equipment integration.
• Standardize automation platforms and documentation practices across the site.

Maintain Compliance and own Computerized System Validation (CSV)

Overview

Ensure all automation systems are validated and maintained in accordance with internal policies and regulatory expectations (GAMP 5, 21 CFR Part 11, EU GMP Annex 11).

Detailed Tasks:

• Oversee CSV activities for new and existing systems.
• Ensure changes are managed under the site change control process.
• Partner with QA and Validation to maintain inspection readiness.
• Support internal and external audits regarding automation and CSV.

GxP

• Has a broad and in-depth understanding of existing and emerging regulatory GxP requirements within own field of expertise.
• Takes GxP requirements very serious during preparation, execution and reporting of GxP activities.

Your Profile:

• Master’s degree in Automation Engineering, or a related field.
• At least ten years of experience, pharma/GMP regulated environment. Strong background in either PLC, SCADA, DCS or MES and manager experience highly preferred

Leadership & Management Skills

• Strong people leadership and coaching skills; ability to develop technical talent.
• Able to foster a culture of ownership, high quality work and continuous improvement.
• Structured and decisive, with good prioritization in a dynamic environment.
• Cross-functional communication and stakeholder management.
• Ability to balance technical depth with GMP and business priorities.

Technical Knowledge

• Strong understanding of GMP, GAMP 5, 21 CFR Part 11, Annex 11, and Data Integrity principles.
• Experience with automation systems such as PLCs, SCADA, DCS, HMIs, MES and historian systems.
• Familiarity with industrial communication protocols (e.g., Profibus, ControlNet, Modbus, Ethernet/IP).
• Understanding of IT/OT integration, virtualization, and cybersecurity in GMP systems.
• Experience with Computerized System Validation (CSV) lifecycle and documentation.
• Preferred: Experience with systems used in pharmaceutical manufacturing (e.g., Siemens, Rockwell, Aveva Citect, PI, system platform, historian).
• System build experience highly desired, e.g. prior work either onsite or with a system integrator either coding, commissioning or troubleshooting and maintaining industrial control systems.

What we offer:

• A market-rate salary
• A budget of 16,66% (holiday allowance and year-end bonus) of your gross salary, yours to spend or to save monthly
• A fulltime employment of 40 hours per week
• Flexible working hours after deliberation
• Your own place in a close-knit and expert team with an employer that stimulates growth and personal development
• Good accessibility by public transport and we provide private parking;
• Sound pension provision.

Responsibilities:

1. GMP Compliance Oversight:
Ensure all maintenance and calibration planning activities strictly adhere to Good Manufacturing
Practices (GMP), maintaining product quality and regulatory compliance.

2. Quality Assurance Management:
Develop and oversee the implementation of quality control procedures for maintenance and
calibration tasks to guarantee equipment reliability, accuracy, and consistency.

3. Scheduling and Coordination:
Plan, schedule, and coordinate preventive and corrective maintenance activities with both internal
teams and external service providers to ensure timely and efficient execution.

4. Preventive Maintenance Planning:
Design and implement preventive maintenance schedules to proactively address potential
equipment issues, reduce downtime, and enhance operational efficiency.

5. Corrective Maintenance Oversight:
Oversee the planning and follow-up of corrective maintenance tasks to promptly resolve
equipment failures, minimizing disruption to production processes.

6. Calibration Strategy Coordination:
Plan, schedule, and monitor calibration activities to ensure equipment accuracy and compliance
with industry standards and regulatory requirements.

7. Vendor Management:
Manage relationships with external service providers, ensuring they adhere to GMP standards and
deliver high-quality maintenance and calibration services within agreed timelines and budgets.

Your profile:

• Bachelor’s degree (HBO-level) required, with specialized expertise in utility systems, GMP regulations, and maintenance management systems (such as SAP-PM)
• 5 years of working experience in pharmaceutical industry
• Understanding of existing regulatory GxP requirements
• Social skills such as tact, persuasiveness, control and being able to deal with conflicting interests are required;
• Stakeholder management skills
• Excellent verbal and written skills in Dutch and English

What we offer:

• Full-time employment (40h) with flexible working hours in consultation. Working part-time can be discussed.
• 8.33% end-of-year bonus and 8.33% holiday allowance.
• A personal training budget of €2,100 every three years to foster professional growth and development.
• Contribution to travel expenses from the first kilometer.
• Excellent accessibility by public transport and private parking available.
• A pension plan with Zorg & Welzijn, providing security for your future.
• A dynamic, safe, and challenging working environment with ample opportunities to grow, innovate, and learn, all while making a meaningful impact on the health of millions.

Key Responsibilities

Utilities Monitoring & Testing

• Perform routine sampling and microbiological/chemical testing of utilities (HPW, WFI, clean steam, compressed air).
• Ensure sampling plans and test methods comply with GMP, SOPs, and regulatory guidelines.
• Operate and maintain laboratory equipment used for utilities testing.

Data Review & Trending

• Review and approve test results for accuracy and completeness.
• Perform data trending and identify deviations or out-of-specification (OOS) results.
• Escalate issues promptly and support investigations.

Compliance & Documentation

• Maintain accurate and complete documentation in accordance with GMP and company SOPs.
• Participate in internal and external audits, providing data and explanations as required.
• Ensure timely reporting and closure of deviations and CAPAs.

Continuous Improvement

• Contribute to risk assessments and contamination control strategies for utilities.
• Support validation and qualification activities for utility systems.
• Identify opportunities for process optimization and efficiency improvements.

Collaboration

• Work closely with Engineering, Production, and QA teams to ensure utility systems remain compliant.
• Provide technical support during investigations and audits.

Your profile

• Bachelor’s degree in Microbiology, Chemistry, Biotechnology, or related field.
• >3 years of work experience in QC utilities monitoring within pharmaceutical or biotech industry.
• Strong knowledge of GMP, EU Annex 1, ISO standards, and regulatory requirements.
• Familiarity with microbiological and chemical testing methods for utilities.
• Excellent attention to detail, organizational, and communication skills.
• Analytical thinking and problem-solving.
• Ability to work independently and in a team environment.
• Commitment to quality and continuous improvement.
• Fluency in English. A conversational level of Dutch is preferred.

What do we offer?

• Full-time employment (40h) with flexible working hours in consultation. Working part-time can be discussed.
• 8.33% end-of-year bonus and 8.33% holiday allowance.
• A personal training budget of €2,100 every three years to foster professional growth and development.
• Contribution to travel expenses from the first kilometer.
• Excellent accessibility by public transport and private parking available.
• A pension plan with Zorg & Welzijn, providing security for your future.
• A dynamic, safe, and challenging working environment with ample opportunities to grow, innovate, and learn, all while making a meaningful impact on the health of millions.

Main responsibilities

In your position as CI Engineer, you will focus on technical aspects and quality aspects of improvement.

In Technical Aspects:

• You will use your experience with and knowledge of equipment, principles and practices of preparative chromatography, column packing, centrifugation, and ultrafiltration/diafiltration (UF/DF), Aseptic Filling lines and Lyophilization in a pharmaceutical environment.
• You will use your experience with manufacturing equipment & auxiliary equipment such as tanks, process instrumentation, autoclaves, washers, clean utilities and CIP/SIP systems.
• You will use your experience with process control and automation, implementing logics on PLC and SCADA is highly preferred.
• You will support continuous improvement teams as per requirement.
• You will prepare Qualification/Validation documentation regarding PQ/PPQ and Process Verification, basic knowledge, commissioning FAT/SAT and qualification IOQ and PQ.
• You will be responsilbe for troubleshooting, root cause analysis, FMEAs, and basic Project Management.

In Quality Aspects:

• You will have a broad understanding of (c)GMP.
• You will handle change controls and CAPAs in an eQMS/eDMS.
• You will have understanding of relevant International guidelines ISPE/ICH/FDA.

Your profile

• Bachelor/ Master degree, including relevant experience, in relevant study such as Pharmaceutical Engineering, Chemical Technology, Mechanical Engineering, (Bio) Process Technology or Biochemistry.
• Thorough GMP and validation knowledge and experience.
• Lean Six Sigma (green belt, black belt) is a nice to have.
• Strong quality awareness and familiar working with deliverables and deadlines.
• Self-starter and team player
• Experience as project team member.
• Fluent in English and (preferred) Dutch – oral & writing – is a necessity; including technical reports.

What do we offer?

• Full-time employment (40h) with flexible working hours in consultation. Working part-time can be discussed.
• 8.33% end-of-year bonus and 8.33% holiday allowance.
• A personal training budget of €2,100 every three years to foster professional growth and development.
• Contribution to travel expenses from the first kilometer.
• Excellent accessibility by public transport and private parking available.
• A pension plan with Zorg & Welzijn, providing security for your future.
• A dynamic, safe, and challenging working environment with ample opportunities to grow, innovate, and learn, all while making a meaningful impact on the health of millions.

Vice President Quality

Location: Amsterdam (NL) or Brussels (BE)
Department: Quality
Reports to: Chief Executive Officer

Key Responsibilities

• Develop and implement the global Quality strategy aligned with corporate objectives.
• Ensure compliance with GMP, EMA, FDA, and other relevant regulatory standards.
• Oversee Quality Systems, including CAPA, audits, risk management, and validation.
• Lead and mentor a high-performing Quality team across multiple sites (Amsterdam, Brussels, and other locations).
• Act as the primary contact for regulatory authorities during inspections and audits.
• Drive continuous improvement initiatives to enhance efficiency and compliance.
• Collaborate with senior leadership to integrate quality into business decisions.

Qualifications & Experience

• Master’s degree in Life Sciences, Pharmacy, or related field; PhD is a plus.
• Minimum 15 years of experience in Quality within the biopharmaceutical industry, with at least 8 years in senior leadership roles.
• Deep knowledge of GMP, regulatory requirements, and quality systems.
• Proven track record in managing global teams and complex projects.
• Strong leadership, communication, and stakeholder management skills.
• Fluent in English; additional languages are an advantage.

Werkzaamheden:

• Je analyseert problemen, verhelpt storingen, voert metingen uit, beoordeelt de metingen, en voert onderhoud en modificaties uit aan mechanische, metrologische en elektrotechnische onderdelen in onze farmaceutische fabriek om de diverse productieprocessen optimaal te laten presteren volgens de gestelde GMP-eisen.
• Je begeleidt en controleert de werkzaamheden van externe bedrijven die onderhoudstaken aan de diverse installaties verrichten.
• Je voert kalibraties uit met betrekking tot temperatuur, druk, gewicht, flow, PH en geleidbaarheid.
• Je voert NEN-keuringen uit en stelt meet- en regelapparatuur in.
• Werkvoorbereidingstaken, zoals het selecteren van geschikte meetapparatuur en materiaal, voorbereiden van benodigde documentatie, en het uitzoeken en selecteren van apparatuur en materiaal voor bestellingen.
• Het verrichten van administratieve werkzaamheden die bij de functie horen, zoals het afhandelen van werkvergunningen, orders/tickets, het invoeren van kalibratiegegevens in SAP en urenregistratie.
• Uitvoeren van mechanische werkzaamheden, zoals het monteren van (regel)kleppen, elektromotoren gekoppeld aan roerwerken, pompen, enz.

Functie eisen:

• Afgeronde MBO-opleiding op het vakgebied van elektrotechniek en instrumentatie, en/of meet- en regeltechniek, bij voorkeur met specialisatie in Kalibratie.
• Werkervaring op het gebied van E&I, Meet en regel en/of kalibratie en/of elektrotechniek.
• Ervaring met PLC-, en meet- en regeltechniek en/of instrumentatie en/of elektrotechniek.
• Ervaring op het gebied van instellen, testen en monteren van meet- en regelapparatuur, waaronder transmitters, frequentieregelaars, (regel)kleppen, elektromotoren gekoppeld aan roerwerken, pompen, enz.
• Het is een pré als je werkervaring hebt gerelateerd aan procestechniek, petrochemie, in de voedings- en/of farmaceutische industrie. Bekend met de regels rondom GMP en/of ISO17025.

Wat we verder van jou verwachten:

• Je werkt nauwkeurig, gestructureerd en zelfstandig en vindt het leuk om met details bezig te zijn.
• Je bent klantgericht en collegiaal en ondersteunt collega’s buiten je eigen team.
• Je toont initiatief en reageert positief en proactief.
• Waar nodig ben je bereid tot het doorlopen van een uitgebreide inwerkperiode binnen Prothya.
• Je bent op zoek naar een werkgever om je langere tijd mee te verbinden.

Ons aanbod:

• Je start op basis van en half jaar detachering, daarna krijg je een contract van Prothya; Een fulltime dienstverband (40 uur);
• 30 vakantiedagen;
• 8,33% eindejaarsuitkering en 8,33% vakantietoeslag;
• Salarisschaal 7 (maximaal € 4.750,00 per maand, op basis van 40 uur. Excl toeslagen etc)
• Persoonlijk opleidingsbudget van €2.000 per 3 jaar;

Accountabilities: 

Asset & Maintenance Management

• In collaboration with the asset engineer, develop and implement preventive and corrective maintenance plans for utility installations (SAP-PM).
• Coordinate with internal and external service providers, initiate optimizations, and ensure documentation and compliance with engineering standards.

Utility Supply & Monitoring

• Ensure 24/7 reliable delivery of black and clean utilities.
• Monitor consumption, quality, and uptime KPIs.
• Follow up on deviations, prepare mitigation plans, and ensure full compliance with cGMP/FDA requirements.
• Forecast future utility needs based on production planning and initiate expansion plans.

Continuous Improvement & Projects

• Identify, lead, and implement improvement projects focused on efficiency, sustainability and cost reduction.
• Monitor monthly costs and forecast annual utility consumption and expenditures.
• Apply LEAN, 5S, and energy optimization principles.

Leadership

• Translates annual departmental business objectives to the team and makes sure the objectives are met. Organizes the activities and tasks of the team.
• Lead the Utilities team. Hire, coach and appraise employees, and develop employees using the relevant HR instruments, service and procedures.
• Ensures collaboration within the team and other departments.

Stakeholder Management

• Serve as the main point of contact for all utility-related questions.
• Facilitate effective communication between Technical Services, Production, QA, SCM, auditors, and external vendors.
• Escalate issues where needed and manage expectations during incidents and improvement initiatives.

EHS

• Actively monitors and enforces compliance with health, safety and environmental procedures within the team. Intervenes on unsafe behavior and ensures availability and proper use of safety tools and instructions.
• Follows all applicable safety procedures and instructions, uses PPE correctly, and immediately reports unsafe conditions or environmental incidents.

Your profile:

• Bachelor’s degree (HBO-level) required, with specialized expertise in maintenance management systems (such as SAP-PM).
• > 5 years of relevant working experience. Experience with utility systems and GMP regulations is considered a plus.
• This position is also open for high potentials who wants to take the first step in a leadership position.
• In possession of the VCA for Operational manager certificate.
• Understanding of existing regulatory GxP requirements (plus)
• Knowledge of guidelines on black and clean utility management (plus)
• Social skills such as tact, persuasiveness, control and being able to deal with conflicting interests are required;
• Stakeholder management skills
• Excellent verbal and written skills in Dutch and English

What We Offer:

• Full-time employment (40h) with flexible working hours in consultation.
• 8.33% end-of-year bonus and 8.33% holiday allowance.
• A personal training budget of €2,100 every three years to foster professional growth and development.
• Contribution to travel expenses from the first kilometer.
• Excellent accessibility by public transport and private parking available.
• A pension plan with Zorg & Welzijn, providing security for your future.
• A dynamic, safe, and challenging working environment with ample opportunities to grow, innovate, and learn, all while making a meaningful impact on the health of millions.

Als EHS Specialist ben je verantwoordelijk voor het bewaken van de implementatie en uitvoering van het EHS-beleid van de organisatie. Dit zodat de organisatie voldoet aan wet- en regelgeving op het gebied van veiligheid, gezondheid en milieu en we onze doelstellingen in de strategie en visie van de organisatie kunnen realiseren.

Je belangrijkste verantwoordelijkheden zijn:

• Je signaleert en analyseert interne en externe ontwikkelingen, knelpunten en afwijkingen op EHS-gebied, beoordeelt deze en adviseert over de consequenties voor de organisatie en doet voorstellen voor bijstelling van het beleid.
• Je ondersteunt bij de implementatie en uitvoering van EHS-beleid en vraagstukken en draagt oplossingsrichtingen aan.
• Je ondersteunt bij het optimaliseren van de bedrijfsvoering en het beheersen van processen zodanig dat de zorg voor EHS-aspecten is geborgd.
• Je draagt zorg voor adequate registratie van EHS-meldingen en escaleert afwijkingen die onvoldoende worden opgepakt of een bedrijfsrisico vormen.
• Je houdt toezicht op de werkzaamheden en maatregelen in geval van calamiteiten. Onderhoudt contacten met controlerende instanties en betrokken partijen in geval van calamiteiten.
• Je onderhoudt contacten met de milieucoördinator van de Prothya campus voor het beheer van de voor de organisatie(onderdelen) benodigde (milieu)vergunningen en de daarvoor benodigde rapportages.
• Je creëert alertheid ten aanzien van EHS aspecten. Rapporteert hiertoe over de stand van zaken en ontwikkelingen en de uitvoering van het EHS-beleid binnen de organisatie, inclusief risicoanalyse en kosten-batenanalyse.
• Je stimuleert het EHS bewustzijn en denkt na over EHS verbeteringen binnen de organisatie. Zoekt contact en samenwerking met het lijnmanagement en geeft informatie en advies over EHS-onderwerpen en best practices.
• Je voert oefeningen en inspecties uit ten behoeve van het toetsen en stimuleren van het EHS-bewustzijn en het werken volgens de EHS-richtlijnen.
• Je neemt deel aan relevante projecten, werkgroepen, netwerken en/of comités.

Je Profiel

• HBO denk- en werkniveau, verkregen door opleiding of werkervaring.
• Relevante werkervaring in een soortgelijke functie.
• Kennis van richtlijnen op het gebied van veiligheid, gezondheid en milieu, principes, wetgeving en best practices.
• Bereidheid om aanvullende trainingen, cursussen of een gerichte opleiding op het gebied van EHS (bijvoorbeeld MVK of HVK) te volgen
• Kennis van de organisatie, processen en procedures.
• Uitstekende communicatieve vaardigheden in het Engels en Nederlands.
• Proactief in het tonen van verantwoordelijkheid en eigenaarschap.

Wat ga je doen?

• Ontvangst: Fysieke en administratieve verwerking (SAP) van binnenkomende producten, inclusief retours, volgens geldende GMP/GDP en PGS-15 richtlijnen.
• Opslag & Voorraadbeheer: Opslag van producten conform voorschriften, controle en verwerking van opslagtemperaturen, voorraadbeheer en -correcties, en batchcoördinatie.
• Transport: Verantwoordelijk voor het veilig transporteren van producten, zowel intern als naar klanten, inclusief het programmeren van temperatuurloggers.
• Afwijkingenregistratie: Signaleren, rapporteren en in overleg aanpakken van afwijkingen om de productkwaliteit en veiligheid te waarborgen.
• Werkplekbeheer: Zorg voor een schone en geordende werkplek, inclusief onderhoud van apparatuur en beheer van benodigde voorraad zoals droogijs en emballage.
• Organisatie & Training: Zelfstandig organiseren van de dagelijkse en wekelijkse afdelingstaken, inclusief piketdiensten voor urgente zendingen, en zorgdragen voor up-to-date training en kwalificatiedocumenten.

Wie ben jij?

• Je hebt een MBO-4 diploma en minimaal 5 jaar werkervaring in logistiek of de farmaceutische industrie, bij voorkeur in een operationele of kwaliteitsrol.
• Je hebt ervaring met ERP-systemen zoals SAP en bent in staat om zelfstandig binnen SOP’s en kwaliteitsrichtlijnen te werken.
• Je beschikt over uitstekende mondelinge en schriftelijke vaardigheden in het Nederlands en een basiskennis Engels.
• Je hebt een praktische instelling en voelt je verantwoordelijk voor kwaliteit, veiligheid en netheid in je werkomgeving.
• Ervaring met vork- en reachtruck is een pre.

Ons aanbod:

• Een fulltime functie met een concurrerend salaris (32 of 26 uur werken is bespreekbaar).
• Een budget van 16,66% (vakantietoeslag en eindejaarsuitkering) van je bruto salaris, dat maandelijks kan worden gebruikt.
• Flexibele werktijden, in overleg.
• Persoonlijk opleidingsbudget van €2.100 elke 3 jaar.
• Bijdrage aan reiskosten vanaf de eerste kilometer.
• Goede bereikbaarheid met het openbaar vervoer, met privéparkeermogelijkheden beschikbaar.
• Pensioenregeling bij Zorg & Welzijn.

 Are you a passionate Talent Acquisition professional ready to make a real impact?

At Prothya, we believe that great people drive great success, and we’re looking for a Talent Acquisition Specialist to help us attract, engage, and hire top talent. In this role, you’ll take full ownership of the end-to-end recruitment process in the Netherlands and support Belgium when needed. You’ll work closely with hiring managers, HR partners, and candidates to ensure a smooth and effective hiring journey. From sourcing high-quality talent to developing strong employer branding initiatives, you’ll play a key role in shaping Prothya’s workforce and ensuring we remain an employer of choice in the pharmaceutical industry.

If you’re a strategic thinker with strong stakeholder management skills, a passion for talent acquisition, and fluency in Dutch & English, we’d love to hear from you !

Ready to build the future with us?

Apply today and be part of a dynamic, purpose-driven team at Prothya.

Accountabilities:

Strategic Quality Management:

• Develops and implements quality assurance strategies and policies within QA projects.
• Ensures alignment of QA projects with corporate strategy and regulatory requirements.
• Manages the budget for QA projects and monitors cost control.

Change Control & Validation:

• Oversees change control processes and reviews and approves change control documentation and validation records.
• Asssures validation requirements and strategies for cGMP documentation are met.
• Coordinates the execution of change control procedures.
• Chair of the Change control board

Compliance and Quality Assurance:

• Ensures QA projects comply with GMP, GDP, and other relevant regulations.
• Acts as a subject matter expert within change control projects, providing compliance guidance.

Stakeholder and Relationship Management:

• Maintains close collaboration with departments such as Production, QC, and Regulatory Affairs.
• Represents QA in management and strategic meetings.
• Supports external audits and maintains relationships with regulatory authorities.

Reporting and Documentation:

• Ensures clear and complete documentation of QA projects, CAPAs, and validation dossiers.
• Analyzes and reports trends and risks to senior management.

Leadership:

• Translates annual departmental business objectives to the team and makes sure the objectives are met. Organizes the activities and tasks of the team.
• Lead the QA Project Team. Hire, coach and appraise employees, and develop employees using the relevant HR instruments, service and procedures.
• Ensures a safe, secure, and healthy work environment.
• Ensures collaboration within the team and other departments

Your profile:

• University level, knowledge on biology, chemistry or biochemistry. Preferably graduated in life sciences, Chemistry, Pharmacy or comparable.
• > 5 years of experience in Pharma.
• Experience in either pharmaceutical production or quality management
• Experience in biotech or sterile manufacturing is preferred
• Leadership experience, ideally experience with leading leaders
• Continuous improvement (CI) experience is preferred (e.g. green belt or black belt or comparable experience)
• Able to be pragmatic when possible and strict when needed
• Strong analytical and problem-solving skills, with the ability to make informed decisions based on data and risk assessment.
• Excellent interpersonal and communication skills, with the ability to collaborate effectively with cross-functional teams and communicate complex quality concepts to stakeholders at all levels.
• Strong leadership and team management abilities, with a focus on mentorship, development, and fostering a culture of quality and compliance.
• Detail-oriented mindset and ability to work in a fast-paced, highly regulated environment.
• Hands-on

Your Responsibilities:

• Plan and coordinate maintenance activities in collaboration with production, planning, and technical teams.
• Perform analysis to optimize downtime and reduce maintenance costs.
• Maintain and update maintenance reports and documentation.
• Oversee adherence to safety and quality standards during maintenance stops.
• Ensure optimal production continuity by liaising with various departments.
• Set up an integrated plan for maintenance, calibration, validation, and production with necessary stakeholders.
• Supervise maintenance teams and external suppliers during maintenance stops.

What You Bring:

• Minimum Bachelor working and thinking level with a technical background (e.g., Mechanical Engineering, Electrical Engineering).
• Experience in a production environment, preferably within the pharmaceutical industry.
• Solid understanding of maintenance processes and techniques.
• Strong organizational and communication skills.
• A proactive attitude with excellent problem-solving abilities.
• Fluency in Dutch and English.
• Proficiency in Microsoft Projects or another complex planning tool.

What We Offer:

• Full-time employment with flexible working hours in consultation.
• Salary between € 4.379,34 to € 6.295,23
• 8.33% end-of-year bonus and 8.33% holiday allowance.
• A personal training budget of €2,000 every three years to foster professional growth and development.
• Contribution to travel expenses from the first kilometer.
• Excellent accessibility by public transport and private parking available.
• A pension plan with Zorg & Welzijn, providing security for your future.
• A dynamic, safe, and challenging working environment with ample opportunities to grow, innovate, and learn, all while making a meaningful impact on the health of millions

Purpose of the Job: As a Senior Engineering Specialist, you will act as the process and technical specialist for our lyophilization and filling processes. You are responsible for troubleshooting, optimizing, development and validation of the freeze dryers and filling lines, in close collaboration with Production, Technical Engineering, and QA/Validation stakeholders. In this role, you are capable of acting as the SME in several multidisciplinary projects, providing strategic technical guidance, and ensuring compliance with national and international quality standards.

Key Accountabilities:

• Identifying and solving process or technical issues arising during routine production.
• Providing key input for all changes related to Freeze Dryers and Filling lines.
• Monitoring and interpreting regulatory developments and industry trends, and translating these into process improvements.
• Developing and implementing SOPs and production documentation based on industry standards and requirements (e.g., EU GMP Annex I).

Required Background:

• Master’s degree in Chemical Engineering, Biomedical Engineering, or a similar discipline.
• Over 5 years of experience in the pharmaceutical industry in a similar role.
• Solid knowledge of Aseptic filling and Lyophilization and proven experience therein.
• Solid knowledge of process validation and proven experience therein.
• Knowledge of up-to-date industry guidelines.
• Knowledge of airflow visualization studies is a plus.

Personal Characteristics:

• Flexible and energetic, with strong perseverance.
• Capable of handling a dynamic environment with changing priorities.
• Hands-on, present on the shop floor when needed.

Challenges:

• Able to find pragmatic solutions within time and budget constraints.
• Capable of following production priorities and understanding the bigger picture.

Expectations:

• Ready to make an immediate impact.

Our Offer:

• A full-time position with a competitive salary.
• A budget of 16.66% (holiday allowance and year-end bonus) of your gross salary, which can be used monthly.
• Flexible working hours, subject to agreement.
• Personal training budget of €2,100 every 3 years.
• Contribution to travel expenses from the first kilometer.
• Good accessibility by public transport, with private parking options available.
• Pension plan with Zorg & Welzijn.

The Qualified Person (QP) certifying the finished product is responsible for ensuring that each finished medicinal product batch has been manufactured in accordance with GMP, the terms of the MIA (Manufacturing and Import Authorization), and the MA (Marketing Authorizations). Also included is the responsibility of the release of blood plasma and all further intermediates according to Annex 14

Your job:

• Perform EU QP certification for all products under Prothya Biosolutions B.V. responsibility including products of contractpartners
• Ensure Quality Compliance with all National and International Regulations and internal company regulations
• Oversight of QMS (Quality Management Reviews), which includes Quality Management Reviews, Quality Agreements, Product Quality Reviews
• Maintenance of the Manufacturing License
• Approve Product Quality Complaints related investigations
• Cooperate with all necessary departments to ensure that communication to the Authorities is appropriate, coordinated and approved

Your profile:

• Pharmacist/MSc in Pharmaceutical Sciences or one of the following scientific disciplines: Biopharmaceutical Sciences, Medicine, (Bio-)Chemistry or Biotechnology or similar course recognized by Regulatory Authority to permit Qualified Person (QP) status as per Article 49 of Directive 2001/83/EC
• A minimum of 5 years of experience in the healthcare/pharmaceutical industry (Production, QC-labs)
• Experience as a QP from biotech or pharmaceutical industry
• Persuasiveness and Decisiveness
• Clear communicator
• Shows sense of urgency and sensitive for the needs of the organization
• Excellent writer
• Fluent in Dutch and English
• Availability for 32-40 hours per week

Our offer:

We offer you a fulltime position with the following employment conditions:

• A market-rate salary
• A budget of 16,66% (holiday allowance and year-end bonus) of your gross salary, yours to spend or to save monthly
• A fulltime employment of 40 hours per week
• Flexible working hours after deliberation
• Your own place in a close-knit and expert team with an employer that stimulates growth and personal development
• Good accessibility by public transport and we provide private parking;
• Sound pension provision.

Over de functie

Als HR Adviseur ben jij het vaste aanspreekpunt voor leidinggevenden en medewerkers bij dagelijkse HR-vraagstukken én bij verzuim. Je speelt een centrale rol in het begeleiden van het Joiner-Mover-Leaver (JML) proces, maar jouw toegevoegde waarde zit vooral in jouw actieve rol bij ziekteverzuim en inzetbaarheid.

Je fungeert als een soort interne case manager: je begeleidt langdurige verzuimtrajecten, zorgt voor afstemming tussen medewerker, leidinggevende en arbodienst, en signaleert proactief mogelijkheden om medewerkers duurzaam inzetbaar te houden of te re-integreren.

Daarnaast werk je nauw samen met de HR Business Partner en draag je bij aan de uitrol van tactische en strategische HR-initiatieven zoals verandertrajecten en beleid.

Wat ga je doen?

• Brede HR ondersteuning
• Begeleiden van het volledige Joiner-Mover-Leaver (JML) proces
• Administratieve verwerking van HR-acties en data in de systemen
• Eerste aanspreekpunt voor leidinggevenden en medewerkers
• Adviseren en coachen van managers op thema’s als functioneren, feedback en ontwikkeling
• Opstellen van HR-rapportages en dashboards
• Digitaliseren en optimalisatie van HR-processen
• Meewerken aan een positieve employee experience, gebaseerd op onze kernwaarden
• HR-content beheren en actualiseren op intranet en andere communicatiekanalen
• Ondersteunen van de HR Business Partner bij reorganisaties, beleidsuitrol en verandertrajecten
• Verantwoordelijkheid nemen voor één of meerdere HR-focusthema’s zoals L&D of C&B, afhankelijk van jouw interesse

Verzuim & Inzetbaarheid

• Actieve begeleiding van verzuimtrajecten als intern casemanager
• Sparringpartner voor leidinggevenden én medewerkers bij verzuim en re-integratie
• Afstemming met arbodienst, bedrijfsarts en andere externe partners
• Signaleren van knelpunten en kansen op het gebied van duurzame inzetbaarheid
• Adviseren over het toepassen van het verzuimbeleid en Wet verbetering poortwachter

Wat breng je mee?

• Een afgeronde hbo-opleiding, bij voorkeur in HRM
• Minimaal 3 jaar ervaring in een vergelijkbare HR-rol
• Affiniteit en/of ervaring met verzuimbegeleiding en inzetbaarheid
• Kennis van wet- en regelgeving rondom verzuim is een pré
• Sterke communicatieve vaardigheden en gevoel voor samenwerking
• Proactieve, oplossingsgerichte houding
• Nauwkeurig, discreet en in staat om zelfstandig te schakelen

Wat wij bieden:

• Een fulltime positie met een competitief salaris.
• Een budget van 16,66% (vakantietoeslag en eindejaarsbonus) van je bruto salaris, dat maandelijks kan worden gebruikt.
• Flexibele werktijden, in overleg.
• Persoonlijk opleidingsbudget van €2.100 elke 3 jaar.
• Bijdrage aan reiskosten vanaf de eerste kilometer.
• Goede bereikbaarheid met het openbaar vervoer, met privéparkeermogelijkheden beschikbaar.
• Pensioenregeling bij Zorg & Welzijn.