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Job Description & How to Apply Below
Key Responsibilities Generate and execute validation lifecycle documentation for GMP regulated assets Support validation activities for tech transfer projects, including authoring and executing validation documents Write and revise qualification and verification documents, and prepare summary reports for validation activities Qualifications and Requirements Bachelor's degree in a life science, engineering, or related technical field 4-7 years of experience in the biotech, pharmaceutical, or medical device industry Strong knowledge of FDA cGMP requirements and risk-based validation principles Hands-on validation experience in equipment and computerized systems Experience generating protocols for automated production systems
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