Process Validation Engineer

Process Validation Engineer – Cell Therapy | CAR-T (EMEA)

Our client is active in the development, manufacturing, and commercialization of CAR-T cell therapies in partnership with a leading biotechnology organization. Together, they are advancing an innovative immunotherapy platform aimed at treating blood cancers and addressing unmet medical needs.

CAR-T therapy is a cutting-edge treatment that leverages a patient’s own immune system. By genetically modifying T-cells to target and eliminate cancer cells, this technology offers new hope to patients for whom existing therapies have shown limited or no success. To support the continued growth of this therapy in Europe, a new state-of-the-art manufacturing facility is being developed in Ghent, Belgium.

The Role

As a Process Validation Engineer, you will be part of the Manufacturing Excellence team and play a key role in the start-up and scale-up of CAR-T manufacturing operations in Ghent. The manufacturing process is being transferred from the US to Europe, with a strong focus on the implementation of the pilot plant.

You will be actively involved in technology transfer, validation planning, sterilization validation, equipment introduction, and technical documentation.

Key Responsibilities

• Define validation strategies and coordinate activities such as sterilization validation, hold-time studies, APQ and APS
• Provide guidance on validation and qualification activities
• Ensure timely revalidation of manufacturing and sterilization processes
• Write, review, and approve validation plans, protocols, and reports (including sterilization and APS)
• Participate in product transfer and system introduction teams
• Contribute to process improvement and optimization projects
• Review technical documentation to ensure compliance with current industry standards, regulatory requirements, and technologies

Experience & Skills

• Experience in pharmaceuticals, biotechnology, cell therapy, plasma-derived products, or a related industry
• Experience introducing pharmaceutical products into manufacturing sites and supporting late-stage development
• Strong knowledge of cGMP
• Experience in aseptic / cleanroom environments is a plus
• Project management skills with clear and timely reporting
• Able to interact effectively at multiple organizational levels
• Comfortable working under pressure and managing competing priorities
• Able to work independently with strong prioritization skills
• Team-oriented with a problem-solving mindset
• Fluent in Dutch and English (written and spoken)
• 5–7 years of relevant experience