Senior Validation Engineer
Job Summary
Seeking a full-time Senior Validation Engineer, the successful candidate will execute commissioning and qualification activities for GMP-regulated facilities, utilities, and manufacturing processes, collaborating cross-functionally to ensure compliance with project timelines and regulatory expectations.
Key Responsibilities
- Review design and qualification documentation to prepare for commissioning and qualification activities
- Execute commissioning and qualification protocols, including IQ, OQ, and PQ, while verifying system functionality and compliance
- Coordinate testing activities with cross-functional teams and document discrepancies, resolutions, and protocol execution deliverables
Required Qualifications
- Bachelor's degree in Engineering, Life Sciences, or a related technical discipline
- 7-11 years of experience in commissioning, qualification, or validation within regulated life sciences industries
- Strong understanding of FDA cGMP requirements and risk-based commissioning methodologies
- Demonstrated experience executing and supporting IQ, OQ, and PQ protocols
- Experience with deviation management and quality systems in a project environment
Complete Job Description
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