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Validation Engineer
2 weeks ago
We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:
- Validation Engineer
We are seeking a skilled Validation Engineer to perform the full qualification of a cold room (2-8°C) for a regulated FDA production site. The engineer will be responsible for executing qualification protocols, ensuring compliance with GMP standards, and delivering comprehensive documentation.
Key Responsibilities:
- Develop and execute protocols: IQ, OQ, PQ, and validation studies (Empty Chamber, Full Chamber, Open Door).
- Author and finalize Validation Plans, Summary Reports, and associated documentation.
- Perform Installation Verification (IV) and Operational Verification (OV).
- Conduct training on client systems and SOPs.
- Use Kneat software for documentation and protocol management.
- Collaborate with client teams to meet project timelines and deliverables.
- Bachelor's degree in Engineering, Life Sciences, or related field.
- 3+ years of validation experience in GMP-regulated environments.
- Strong experience in cold room qualifications and thermal mapping studies.
- Proficiency with Kneat software (required).
- Strong understanding of FDA regulatory requirements and GMP standards.
- Ability to work independently and meet project deadlines.
