Job description
About the Role
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.
As CAR‑T QA C&Q Engineer, you will be responsible for the review and approval of qualification and requalification activities related to Facilities & Utilities (F&U) and Process Equipment at the CAR‑T manufacturing facilities.
Key Responsibilities:
* Work closely with Make Asset Management (MAM) and Engineering & Property Services (E&PS) to:
o Guard the qualification status of critical production assets.
o Ensure all system critical aspects related to facilities & utilities, product, and process requirements are identified, qualified, and controlled via appropriate mitigation plans.
o 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:
o Review and approve new change controls.
o 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:
o Reviewing and approving procedures (e.g., calibration rationales, calibration master forms, completed calibration records).
o Overseeing master data set‑up, maintenance plans, and daily operations activities.
o 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:
o Change controls, master documents, protocols, reports, rationales, SOPs, URS, IA, QSR, etc.
o 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.
Candidate Profile:
Education & Background
* 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).
Technical Skills
* 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:
o System parameter configuration
o Data integrity principles and controls
Soft Skills
* 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
Why joining us?
Rapid growth: Amaris has doubled its workforce in Belgium in two years, providing numerous growth opportunities for employees.
Prestigious projects: Candidates will work with renowned clients in the pharmaceutical, biotechnology, and European institutions sectors on impactful missions.
International environment: An agile and dynamic structure promotes intrapreneurship and meritocracy, with international exposure at the heart of Europe.