Senior Validation Engineer - GMP Compliance Lead

Posted 9 days ago

katalyst croCharleston (SC)

SENIORITY

Lead

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About the role

Katalyst CRO is seeking an experienced Senior Validation Specialist to lead qualification and validation activities in a GMP-regulated environment. You will plan, execute, review, and approve validation documentation for equipment, processes, and computerized systems while ensuring compliance with FDA, EMA, and cGMP regulations. Responsibilities include leading DQ/IQ/OQ/PQ, authoring validation plans and reports, and mentoring junior staff.

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