Validation Manager

Responsibilities Responsible for validation programs in support of GMP manufacturing Responsible for facility, utility and equipment qualification programs Responsible for QA role in process and assay validation programs Review or author validation related documents such as design specification, URS, FAT, SAT, IQ, OQ, PQ for utility and equipment Assume QA lead role in software validation Maintain and update validation master plans Execute validation protocols as required Oversee QA aspects of calibration and preventive maintenance programs used in GMP manufacturing Supervisor, mentor validation staff with the goal of building a sustaining validation team Serve as the primary QA representative for interaction with internal function departments and contractor on validation activities Qualification BS/MS in life science or related field 12+ years experience in drug/biologics industry in GMP production environment in roles of validation/engineering 10+ years experience in facility, utility, equipment, instrument validation Experience in biotechnology facility validation is required Familiar with GMP operational principles and practices QC experience helpful Works independently, self-motivated, and results oriented

Created: 2024-11-05