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ATLValidation Engineer – Cold Room Qualification; NC
Job in
Greenville, Pitt County, North Carolina, 27834, USA
Listed on 2026-01-15
Listing for:
Validation & Engineering Group, Inc.
Full Time
position Listed on 2026-01-15
Job specializations:
-
Engineering
Quality Engineering, Validation Engineer
Job Description & How to Apply Below
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Validation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas:Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services. Position
Validation Engineer
Job DescriptionWe 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.
Mid-Senior level
Employment TypeContract
Job FunctionStrategy/Planning and Information Technology
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