C&Q Engineer

CAR-T QA C&Q Engineer

About the role

An innovative biopharmaceutical manufacturing organization is seeking a CAR-T QA C&Q Engineer to support its European CAR-T hub in the Ghent region, Belgium. The site is part of a broader expansion of CAR-T manufacturing capacity in Europe, with production activities in Ghent and related laboratory operations in Beerse.

CAR-T therapy is an advanced cell therapy approach that uses a patient’s own T-cells, engineered to target and eliminate cancer cells expressing a specific antigen. This position sits within the QA Qualification team and focuses on the quality oversight of qualification and requalification activities for facilities, utilities, and process equipment used in a GMP-regulated manufacturing environment.

Responsibilities

• Provide QA oversight for qualification and requalification activities related to facilities, utilities, and process equipment in a CAR-T manufacturing environment.
• Safeguard the qualified status of critical production assets by ensuring system-critical aspects, product requirements, and process requirements are identified, qualified, and controlled through appropriate mitigation plans.
• Review and assess equipment-related deviations with potential quality or compliance impact, ensuring robust investigations and effective corrective and preventive actions.
• Partner closely with manufacturing, engineering, and asset management stakeholders to review change controls and maintain compliance of production assets.
• Review and approve qualification lifecycle documents, including change controls, protocols, reports, SOPs, rationales, URS, impact assessments, and related discrepancy or non-conformance records.
• Review and approve compliance-related documentation such as calibration rationales, calibration master forms, completed calibration records, master data setup, and maintenance plans.
• Support day-to-day data integrity oversight through review and approval of deliverables such as audit trail reviews and user access reviews for critical systems.
• Participate in inspection readiness activities and represent QA Qualification during regulatory or customer inspections.
• Contribute to continuous improvement initiatives and maintain current knowledge of applicable international regulations, guidelines, and industry practices.

Candidate profile

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

Preferred background

Candidates with prior experience in GMP qualification, validation, commissioning, QA engineering, sterile manufacturing, biologics, advanced therapies, or highly regulated pharmaceutical production environments are likely to be well aligned with this role.

Location

This role is based in the Ghent area, Belgium, within a growing European CAR-T manufacturing hub.