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Validation Engineer, Sterile
Hcfa · Brookhaven, NY, United States
About The Role
The Validation Engineer, Sterile, supports validation and qualification activities for manufacturing and packaging equipment, facilities, utilities, and systems in a sterile GMP environment. Prepares and executes FAT/SAT, IQ/OQ, PQ, and requalification protocols and reports, ensuring documentation meets specifications, cGMP standards, and site procedures. Coordinates activities with Engineering, Manufacturing, Quality, vendors, and contractors; documents deviations; and supports timely resolution, change control, CAPA, and continuous improvement.
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