Validation Engineer
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Job Summary
Seeking a Validation Engineer with 4-7 years of experience, this full-time position will develop, execute, and maintain validation lifecycle documentation while ensuring compliance with GMP regulations and collaborating with cross-functional teams in a dynamic environment.
Key Responsibilities
- Develop, review, execute, and maintain commissioning, qualification, and validation protocols and reports within the Kneat validation system
- Generate and execute validation lifecycle documentation for equipment, utilities, facilities, and laboratory systems in compliance with regulatory requirements
- Collaborate with Engineering, Manufacturing, and Quality teams to ensure successful execution of validation activities and support technology transfer projects
Required Qualifications
- 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 (CSV)
- Demonstrated experience writing IQ, OQ, PQ, and CSV reports
Complete Job Description
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