QA C&Q Engineer Pharmaceuticals F​/M​/X

CAR‑T QA C&Q Engineer

We are looking for a CAR‑T QA C&Q Engineer to join the CAR‑T QA Qualification team within a cutting‑edge cell therapy manufacturing hub in Europe.

CAR‑T (chimeric antigen receptor T‑cell therapy) is an innovative immunotherapy that uses a patient’s own T‑cells, engineered to recognize and eliminate cancer cells expressing specific antigens. To support the CAR‑T program in EMEA, two CAR‑T manufacturing centers have been established in the Ghent area, with QC laboratories operated from an existing site in Beerse.

• 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, and 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, evaluate and investigate deviations with potential impact on quality and/or compliance and address them 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 (e.g., calibration rationales, calibration master forms, completed calibration records), overseeing master data set‑up, maintenance plans, and daily operations activities, and 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, including change controls, master documents, protocols, reports, rationales, SOPs, URS, IA, QSR, etc., and discrepancies/events/non‑conformances and related corrective actions occurring during qualification activities.
• 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, including system parameter configuration and 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

Amaris Consulting is proud to be an equal opportunity workplace. We are committed to promoting diversity within the workforce and creating an inclusive working environment. For this purpose, we welcome applications from all qualified candidates regardless of gender, sexual orientation, race, ethnicity, beliefs, age, marital status, disability, or other characteristics.