Commissioning & Qualification (C&Q) Supervisor – Cell Therapy Manufacturing
Location: Flanders, Belgium
Work Schedule: Monday-Friday, 9:00-17:00 (Flexible: 10:00-16:00 core hours)
Contract Type: Full-time (40 hours/week)
We are hiring a C&Q Supervisor to join our team supporting clinical and commercial personalized cell therapy manufacturing operations. You will be part of a dedicated asset management team within Technical Operations, responsible for ensuring compliant, safe, and efficient commissioning and qualification (C&Q) processes across our cGMP manufacturing sites.
This position is ideal for a driven individual with strong technical, leadership, and GMP knowledge who is eager to contribute to advanced cell therapy production in a regulated, cutting-edge environment.
Key Responsibilities
Oversee day-to-day C&Q activities for process and lab equipment used in cGMP production
Lead a team of 8 C&Q engineers, providing coaching, development plans, and conducting evaluation interviews
Ensure robust execution of C&Q protocols, periodic system quality reviews, user access reviews, and audit trail management
Serve as a primary escalation point for issues and drive resolution in collaboration with cross-functional teams
Coordinate technical investigations related to commissioning and qualification
Support and contribute to documentation efforts including Critical Aspects Risk Assessments (CARA), Test & Traceability Matrices (T&TM), Project Plans, Master Plans, and Periodic System Quality Reviews (PSQR)
Ensure activities align with internal Quality and EHS policies, cGMP standards, and local/international regulations
Manage multiple C&Q projects simultaneously, balancing deadlines, resources, and priorities effectively
Required Qualifications
Master’s degree in Engineering, Bioengineering, Biomedical Sciences, or a related technical field
4-5 years of relevant C&Q experience in a cGMP environment, preferably in aseptic or life science manufacturing
Proven leadership and people management experience
Deep understanding of Good Engineering Practices (GEP), GMP, and regulatory expectations (FDA/EU)
Fluent in Dutch and English
Strong analytical, organizational, and communication skills
Proficiency in Microsoft Office tools. Experience with SAP, electronic document management systems, and change control systems is a plus
What We Offer
Benefits:
Laptop and mobile phone
€100/month net expense allowance
Meal discount in on-site restaurant
20 vacation days + 12 ADV days (32 total)
Group & hospital insurance
Career Growth
Exposure to cutting-edge technologies, coaching opportunities, and structured evaluation cycles
Hiring Process
HR Interview – Initial screening and culture fit
Team Interview – Technical and managerial assessment
Case Study & Presentation – Prepare and present a business case to senior stakeholders within 72 hours
