GMP Validation Lead Engineer

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, facilities, utilities, processes, and computerized systems to ensure FDA/EMA compliance.

Responsibilities include leading DQ/IQ/OQ/PQ, authoring validation protocols, executing validations, managing CAPA and change controls, and mentoring junior staff.