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.