Senior Engineer, CSV Validation
This role involves end-to-end ownership of computerised system validation (CSV) for GxP-regulated systems used in the manufacturing and testing of advanced CAR-T cell therapies. The engineer will author and execute validation documentation, ensure compliance with international regulations (e.g. FDA 21 CFR Part 11, EU GMP Annex 11), manage change controls and CAPAs, and support regulatory inspections. The position requires strong technical writing, cross-functional collaboration, and expertise in GAMP 5 and data integrity within a biopharmaceutical context.