CSV Validation Engineer - Automation & GMP

SimoTech is recruiting a CSV Engineer to support validation for a Drug Product Facility project in Co. Dublin. The role requires 6+ years in GMP and validation, with hands-on experience authoring C&Q plans, URS, FAT and IOQ documentation and leading cross-functional teams.

Deep familiarity with 21 CFR Part 11, Eudralex Annex 11, and GAMP 5 is essential. You will ensure compliance and traceability across validation deliverables, maintain SDLC templates, and drive risk assessment and knowledge