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Katalyst CRO

GMP Validation Lead Engineer

raleigh, NC

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About this opportunity

Katalyst CRO lists this GMP Validation Lead Engineer opportunity in raleigh, North Carolina. Review the employer’s description below for duties, qualifications and application requirements.

Job description

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.

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Worksite address

raleigh, NC, 27601, US

Who can apply

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