Job at a glance
Roles &Responsibilities • Support single-use system (SUS) setup, use, and inspection within a biologics manufacturing environment • Perform defect detection and integrity checks on single-use assemblies and components • Carry out decontamination procedures for equipment, materials, and manufacturing areas per site protocols • Update and maintain NPI documentation, including single-use diagrams (SUDs) and related schematics • Raise, assess, and progress change controls related to manufacturing and single-use processes • Author and investigate deviations, driving root cause analysis and corrective actions • Liaise cross-functionally with Manufacturing, NPI, and Quality to ensure documentation and processes stay current Requirements • Minimum ~5 years' experience in a biologics/biopharmaceutical manufacturing environment (GMP) • Solid working knowledge of single-use systems/technology, including defect detection • Manufacturing background with hands-on decontamination experience • Demonstrated experience with change control processes • Demonstrated experience authoring/investigating deviations • Exposure to NPI documentation an advantage