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About the role

Leading validation activities in a GMP regulated environment, the full-time California Licensed Validation Engineer with 7-11 years of experience will develop, execute, and manage validation lifecycle documentation while ensuring compliance with regulatory standards and providing mentorship to junior team members.
Key Responsibilities: Lead the generation and execution of validation lifecycle documentation for equipment, utilities, and manufacturing processes Oversee validation activities for tech transfer projects, including authoring and reviewing validation documents Provide technical mentorship and guidance to junior validation staff while collaborating cross-functionally to meet project timelinesRequired QualificationsBachelor's degree in a life science, engineering, or related technical field 7-11 years of experience in the biotech, pharmaceutical, or medical device industry Strong knowledge of FDA cGMP requirements and risk-based validation principles Advanced validation expertise in equipment and computerized systems validation Demonstrated experience supporting audits and regulatory inspections

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JOB OVERVIEW

Experience level

Lead

Location

New York, NY

Occupation

Validation Engineers

Industry

Pharmaceutical Preparation Manufacturing

Posted

2 days ago

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