Biologics Validation Specialist

Job description

Biologics Validation Specialist Position Summary: Work Schedule: Monday – Friday 1st shift 100% onsite Catalent’s Kansas City (KCM) facility is a premier site for integrated drug development, manufacturing, and clinical supply services, supporting a wide range of pharmaceutical and biotech products. With cutting-edge technologies and a collaborative work environment, it offers exciting opportunities for professionals across all functions—from science and engineering to operations and logistics. The Biologics Validation Specialist serves as a validation representative for laboratory validation activities, including Equipment Qualification and system administration. The Role: Generate, execute and summarize validation documentation for process equipment qualification Lead Validation/Qualification/CSV efforts for equipment purchased or modified (FAT, SAT, OQ, PQ) Coordinate with Quality, technical scientists, and vendors for validation protocols, execution, and final reports Generate, execute and summarize project plans, conduct and peer review change controls, review validation related exceptions events, as well as provide input to site as a SME Contribute to the development and revi...