What you stand to gain

Take part from the inside in the deployment of one of the most innovative therapies in oncology: CAR-T cell therapy (chimeric antigen receptor T-cell therapy). This role places you at the heart of the qualification operations for a CAR-T manufacturing hub in Belgium, in an environment where every qualified asset directly contributes to the safety of patients in treatment. It is a high-level technical and regulatory role, within a team being built around a future-defining technology.

Why this role exists

Two CAR-T manufacturing centres have been established in the Ghent area to support the CAR-T programme in EMEA. To ensure the regulatory compliance of these critical facilities, the QA Qualification team is looking for an engineer specialised in the qualification of production equipment and facilities and utilities, capable of defending the quality strategy in front of health authorities.

What you will do day to day

•      Review and approve qualification and requalification documents for production equipment, facilities, and utilities (IQ/OQ/PQ, protocols, reports, SOPs, URS, change controls, CAPAs, discrepancies).

•      Maintain the qualification status of critical production assets: identify critical aspects, ensure their control, and manage mitigation plans.

•      Evaluate deviations with potential quality or compliance impact, and define appropriate corrective and preventive actions.

•      Manage the compliance status of computerised systems: audit trail reviews, user access management, master data, maintenance and calibration plans.

•      Participate in the preparation and conduct of regulatory and customer inspections as QA qualification spokesperson.

•      Contribute to system and process improvement and optimisation projects.

Your environment

You are part of the CAR-T QA Qualification team in Ghent, working closely with the MAM (make asset management), E&PS, manufacturing, and other quality organisations. Cross-functional environment, in constant evolution. Fully on-site in Ghent.

What we are looking for

•      Master's degree in engineering with a chemistry or analytical background, or in pharmaceutical sciences.

•      Knowledge of cGMP regulations and FDA/EU guidelines applicable to cell therapy manufacturing.

•      Affinity with computerised systems, system parameter configurations, and data management in critical production assets.

•      Fluent in Dutch and English, both written and spoken.

•      Strong analytical thinking, risk assessment, and cross-functional communication skills.

Before you apply

This role is set in a fast-evolving environment where procedures, tools, and teams are still being built. It requires strong adaptability, comfort with complex computerised systems, and the ability to defend quality positions with demanding technical and regulatory stakeholders. If you are looking for a well-established, predictable setup, this is not yet that role.

Ready to apply?

Send your CV to ngrancher@squipp.be with the subject line Application – QA Qualification CAR-T. We respond to every application within 5 business days.

Equal opportunity

All qualified applicants will be treated equally without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, or any other protected status in accordance with applicable law.