Process Validation
Location: Ghent, Belgium
Contract: Until December 2027
Working Pattern: Full-time, on-site
Hours: 40 hours per week
Role Overview
We are looking for experienced Process Validation Engineers to support the start-up and implementation of an advanced cell therapy / CAR-T manufacturing operation in Ghent.
Working as part of the Manufacturing Excellence team, you will support technology transfer, process validation, sterilisation validation, equipment introduction and technical documentation within a GMP manufacturing environment.
Key Responsibilities
- Define, plan and coordinate process validation activities including:
- PPQ
- APS / media fills
- Smoke studies
- Hold-time validation
- APQ
- Support validation and qualification strategy.
- Execute and support sterilisation validation and revalidation activities.
- Write, review and approve validation plans, protocols and reports.
- Participate in technology transfer and new product/process introduction.
- Support equipment and manufacturing system introductions.
- Participate in process improvement and optimisation projects.
- Review technical documentation to ensure compliance with current GMP and regulatory requirements.
- Work closely with manufacturing, quality, engineering and technical teams.
Requirements
- Bachelor's degree or higher in Engineering, Biotechnology, Biomedical Sciences, Pharmacy or a related discipline.
- Approximately 4-6+ years' experience within pharmaceutical, biotechnology, cell therapy, plasma-derived products or a related GMP industry.
- Hands-on process validation experience.
- Strong understanding of cGMP requirements.
- Experience supporting technology transfer or introduction of pharmaceutical products/processes into manufacturing.
- Strong validation documentation skills, including protocols and reports.
- Experience with aseptic/sterile manufacturing, cleanrooms, APS/media fills or sterilisation validation is highly advantageous.
- Strong communication, problem-solving and project coordination skills.
- Able to work independently within a fast-paced manufacturing environment.
- Fluent in both Dutch and English.
- Able to work on-site in Ghent, Belgium.
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