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:
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 (e.g., calibration rationales, calibration master forms, completed calibration records).
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, including:
Change controls, master documents, protocols, reports, rationales, SOPs, URS, IA, QSR, etc.
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:
System parameter configuration
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.
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.
Who are we?
Amaris Consulting is an independent technology consulting firm providing guidance and solutions to businesses. With more than 1000 clients across the globe, we have been rolling out solutions in major projects for over a decade – this is made possible by an international team of 7,600 people spread across 5 continents and more than 60 countries. Our solutions focus on four different Business Lines: Information System & Digital, Telecom, Life Sciences and Engineering. We’re focused on building and nurturing a top talent community where all our team members can achieve their full potential. Amaris is your steppingstone to cross rivers of change, meet challenges and achieve all your projects with success.
At Amaris, we strive to provide our candidates with the best possible recruitment experience. We like to get to know our candidates, challenge them, and be able to give them proper feedback as quickly as possible. Here's what our recruitment process looks like:
Brief Call: Our process typically begins with a brief virtual/phone conversation to get to know you! The objective? Learn about you, understand your motivations, and make sure we have the right job for you!
Interviews (the average number of interviews is 3 - the number may vary depending on the level of seniority required for the position). During the interviews, you will meet people from our team: your line manager of course, but also other people related to your future role. We will talk in depth about you, your experience, and skills, but also about the position and what will be expected of you. Of course, you will also get to know Amaris: our culture, our roots, our teams, and your career opportunities!
Case study: Depending on the position, we may ask you to take a test. This could be a role play, a technical assessment, a problem-solving scenario, etc.
As you know, every person is different and so is every role in a company. That is why we have to adapt accordingly, and the process may differ slightly at times. However, please know that we always put ourselves in the candidate's shoes to ensure they have the best possible experience.
We look forward to meeting you!
