C&Q Engineer
Location: Belgium (Ghent)
Contract End Date: 31 December 2026
IMPORTANT REQUIREMENTS - PLEASE READ FIRST
- Must be able to work on site in Belgium
- Must speak Dutch and English fluently
- Must hold an EU passport or have existing EU work authorization
- No visa sponsorship or relocation sponsorship available
Job Overview
An innovative pharmaceutical manufacturing organization is seeking a CAR‑T QA C&Q Engineer to support its cell therapy manufacturing operations in Europe.
This role is part of a Quality Assurance Qualification team and is responsible for the review and approval of qualification and re‑qualification activities for Facilities & Utilities (F&U) and Process Equipment within GMP manufacturing and quality control environments. The role works closely with Manufacturing, Engineering, Asset Management, and Quality teams to ensure ongoing compliance, inspection readiness, and lifecycle management of critical production assets.
Key Responsibilities
The successful candidate will:
- Work closely with Asset Management and Engineering & Project Services teams to maintain the qualified status of critical production assets, ensuring:
- Identification and qualification of all critical system aspects related to facilities, utilities, product, and process requirements
- Appropriate mitigation plans are in place to control and manage risks
- Deviations related to equipment issues with potential quality and/or compliance impact are thoroughly investigated and resolved through effective corrective and preventive actions
- Collaborate with Manufacturing to review and approve change controls and ensure deviations with potential quality or compliance impact are properly investigated and closed
- Build strong working relationships across multiple Quality organizations
- Manage the compliance status of critical production assets through review and approval of:
- Calibration rationales, calibration master forms, and completed calibration records
- Master data setup and maintenance plans
- Routine operational activities, including data integrity deliverables such as system audit trails and user access reviews
- Participate in preparation for regulatory and customer inspections and act as the QA representative for qualification activities
- Review and approve qualification documentation, including:
- Change controls, protocols, reports, rationales, SOPs, URS, impact assessments, and quality system records
- Documentation related to discrepancies, events, non‑conforming situations, and related corrective actions
- Contribute to system and process improvement and optimization initiatives, ensuring ongoing quality and compliance
- Maintain up‑to‑date knowledge of international regulations, guidelines, and industry best practices and act as a QA subject‑matter expert for qualification activities
Qualifications
Education
- Master's degree in Engineering (chemistry or analytical background) or Pharmaceutical Sciences
Experience & Skills
- Strong quality mindset with knowledge of cGMP regulations and EU/FDA guidance related to cell therapy manufacturing
- Experience supporting, defending, or presenting quality strategies and documentation during health authority inspections
- Strong affinity with computerized systems, system parameter configuration, and data management for critical production assets
- Strong communication skills and ability to work cross‑functionally in a dynamic and changing environment
- Strong analytical thinking, risk assessment, and problem‑solving capabilities
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