Senior Validation Engineer
Job Summary
Leading validation activities in a GMP regulated environment, the full-time Senior Validation Engineer will develop, execute, and manage validation lifecycle documentation while providing technical mentorship and ensuring compliance with regulatory standards.
Key Responsibilities
- Lead the generation and execution of validation lifecycle documentation for various GMP regulated assets
- Oversee validation activities for tech transfer projects, including authoring and reviewing validation documents
- Provide technical mentorship to junior validation staff and collaborate cross-functionally to align validation activities with 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 expertise in equipment and computerized systems validation
- Experience supporting audits and regulatory inspections
Complete Job Description
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