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