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Your Role
As a Process Validation Engineer, you will contribute to the successful start-up and scale-up of CAR-T cell therapy manufacturing in Ghent. You will work with cross-functional teams to ensure validation activities meet regulatory and quality standards and support the transfer of the therapy from the US to Belgium.
- Define, plan, and coordinate validation activities including hold time validation, Annual Product Quality, Annual Product Summary, smoke studies, and process validation.
- Provide guidance on validation and qualification activities, including revalidation of manufacturing and sterilization processes.
- Write, review, and approve process validation plans, protocols, and reports, including APS documentation.
- Participate in product transfer and system introduction teams supporting implementation of the CAR-T pilot plant in Ghent.
- Contribute to system and process improvement and optimisation projects.
- Review technical reports and information to ensure validation and procedures align with cGMP, regulatory requirements, and current industry technology.
Your Profile
Applicants should have a Bachelor's degree or higher in Engineering, Biotechnology, Biomedical Sciences, Pharmacy, or a related discipline, along with 2–5 years of experience in the pharmaceutical, biotechnology, cell therapy, human plasma-derived products, or related industry.
- Hands-on knowledge of manufacturing site unit operations and product introduction processes.
- Strong knowledge of cGMP regulations, process validation methodologies, and sterilization validation.
- Experience in a controlled cleanroom or aseptic environment is a plus.
- Strong problem-solving, collaboration, prioritisation, and communication skills.
- Fluency in English is required; Dutch is an asset.
What You Will Love About Working Here
- Free access to learning platforms and curated programs.
- Mentoring programs supporting professional growth and empowerment.
- Hybrid working arrangements determined with managers.
- FlexAbroad, allowing eligible employees to work abroad for up to 45 days in a 12-month period.