California Licensed Validation Engineer
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Job Summary
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 timelines
Required Qualifications
- Bachelor'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
Complete Job Description
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