Validation Engineer

📋 Description

• Lead the preparation and execution of validation lifecycle documentation, including FAT, SAT, IQ
• Oversee validation activities for internal and client technology-transfer projects, including
• Write, review, and update qualification and verification documentation, including SOPs, validation
• Prepare comprehensive summary reports covering validation, verification, commissioning, and
• Develop and support procedures, investigations, protocols, reports, and change controls in
• Lead P&ID walkdowns to verify system installation, configuration, and readiness.

🎯 Requirements

• Bachelor’s degree in Life Sciences, Engineering, or a related technical discipline.
• 7–11 years of experience in the biotechnology, pharmaceutical, or medical device industry.
• Strong understanding of FDA current Good Manufacturing Practices (cGMP), Failure Mode and Effects
• Advanced expertise in equipment validation, computerized systems validation (CSV), analytical
• Extensive experience developing protocols for automated production systems, particularly
• Demonstrated ability to author and review IQ, OQ, PQ, and CSV documentation and reports.

🎁 Benefits

• Annual base salary range of $110,000–$125,000, depending on experience, qualifications, geographic
• Annual incentive plan.
• Comprehensive benefits package.
• Flexible paid time off and company-paid holidays.
• Flexible working hours.
• Fully remote work options for most positions, with the flexibility to work from various locations.