This position serves as a validation representative for laboratory validation activities, including Equipment Qualification and system administration. In addition, this position is expected to provide technical guidance as A SME with respect to validation/process deviations and change controls as pertains to validation impact.

II. Essential Functions

• 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.<...