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