Job-ID32950698Reference26-01645Roles & Responsibilities: Execute validation studies, including performance qualifications and re-qualifications of manufacturing and laboratory equipment or processes. Assist with writing and executing Commissioning, Qualification, and Validation (CQV) protocols supporting cGMP manufacturing, fill-finish operations, and QC laboratories. Author acceptance reports and provide validation activity updates to project teams. Support facility and utility expansions, compliance upgrades, process improvements, construction projects, and related initiatives. Apply Good Documentation Practices, cGMP requirements, and current industry practices to equipment and systems validation. Collaborate with Manufacturing, Quality Assurance, Engineering/Maintenance, and Quality Control teams. Review change controls, work orders, document change requests, and vendor-generated validation protocol packages. Update applicable SOPs following completion of validation activities. Support limited multi-shift operations, training, and testing as needed. Required skills: Minimum 3–5 years of experience in a sterile pharmaceutical and FDA-regulated industry. Validation experience. Sterile manufacturing experience. Working knowledge of Microsoft Office applications. Knowledge of cGMP requirements, Good Documentation Practices, and validation of manufacturing and laboratory equipment or processes. Strong technical writing, communication, organization, and cross-functional collaboration skills. Familiarity with equipment and systems such as mix tanks, autoclaves, vial/syringe fillers, HVAC systems, and aseptic processing areas. Education Associate of Science degree in a technical or scientific discipline required, or three years of related experience in lieu of a degree. Bachelor of Science degree desired.
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