Manufacturing Engineer

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