QA C&Q Engineer Pharmaceuticals

• Review and approval of qualification and requalification activities related to Facilities & Utilities (F&U) and Process Equipment at the CAR‑T manufacturing facilities
• Work closely with Make Asset Management (MAM) and Engineering & Property Services (E&PS) to guard the qualification status of critical production assets
• Ensure all system critical aspects related to facilities & utilities, product, and process requirements are identified, qualified, and controlled via appropriate mitigation plans
• Ensure deviations related to equipment issues with potential impact on quality and/or compliance are evaluated, thoroughly investigated, and that adequate corrective and/or preventive actions (CAPA) are defined and implemented
• Collaborate with the manufacturing department to review and approve new change controls
• Ensure deviations with potential impact on quality and/or compliance are evaluated, investigated, and addressed with appropriate CAPAs
• Build strong connections with different quality organizations and stakeholders
• Manage the compliance status of critical production assets by reviewing and approving procedures
• Overseeing master data set‑up, maintenance plans, and daily operations activities
• Reviewing and approving data integrity deliverables such as system audit trail and user access reviews
• Participate in preparation for regulatory and customer inspections and act as QA Qualification spokesperson when required
• Review and approve qualification documentation
• Contribute to system and process improvement/optimization projects, ensuring quality and compliance aspects are embedded
• Maintain up‑to‑date knowledge of international regulations, guidelines, and industry best practices related to cell therapy manufacturing and act as QA process expert

• Master’s degree in Engineering (with chemistry or analytical background) or in Pharmaceutical Sciences
• 4–6 years of experience in a GMP‑regulated environment, ideally within biotech, pharma, or advanced therapies (cell/gene therapy is a plus)
• Solid awareness of quality and strong knowledge of cGMP regulations
• Understanding of FDA/EU guidance related to manufacturing of cell therapy products
• Ability and motivation to defend quality strategies and documentation during health authority inspections
• Affinity with computerized systems and data management in critical production assets: System parameter configuration, Data integrity principles and controls
• Strong analytical thinking and risk assessment capabilities
• Excellent communication skills, both written and verbal
• Proven collaboration and teaming skills
• able to work cross‑functionally in a dynamic, continuously changing environment
• Proactive, solution‑oriented mindset with attention to detail
• Fluency in Dutch and English is mandatory

cell/gene therapy experience

• Rapid growth opportunities
• Prestigious projects with renowned clients
• International environment