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
