CAR‑T QA C&Q Engineer

About the role

An innovative biopharmaceutical manufacturing organization is expanding its CAR‑T production capacity in the Ghent region of Belgium. The company seeks a QA C&Q Engineer to provide quality oversight for qualification and re‑qualification activities within a GMP‑regulated cell‑therapy manufacturing environment.

Key responsibilities

• Provide QA oversight for qualification and re‑qualification of facilities, utilities and process equipment used in CAR‑T manufacturing.
• Safeguard the qualified status of critical production assets by identifying, qualifying and controlling system‑critical, product and process requirements.
• Review equipment‑related deviations, lead investigations and ensure effective corrective and preventive actions.
• Partner with manufacturing, engineering and asset‑management teams to review change controls and maintain compliance.
• Approve qualification lifecycle documents such as protocols, reports, SOPs, URS, impact assessments and discrepancy records.
• Approve calibration rationales, master forms, calibration records, master data setup and maintenance plans.
• Support data‑integrity activities including audit‑trail and user‑access reviews for critical systems.
• Participate in inspection readiness and represent QA Qualification during regulatory or customer inspections.
• Contribute to continuous‑improvement initiatives and stay current with international regulations and industry practices.

Required profile

• Master’s degree in engineering (chemistry/analytical focus) or pharmaceutical sciences.
• Strong understanding of quality systems, cGMP regulations and FDA/EU guidance for cell‑therapy manufacturing.
• Experience or strong affinity with computerized systems, system‑parameter configuration and data management for critical assets.
• Analytical thinking, risk‑assessment capability and excellent communication skills.
• Proven ability to work cross‑functionally in a fast‑changing manufacturing environment.
• Fluent in Dutch and English, both spoken and written.

Required skills

• cGMP regulations
• FDA guidance for cell therapy
• EU guidance for cell therapy
• Computerized systems
• System‑parameter configuration
• Data management for production assets
• Calibration management
• Audit‑trail review
• User‑access review