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.

Contribute to the development and...