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ATL01-121724 Validation Engineer – Cold Room Qualification

3 weeks ago

Greenville, United States Validation & Engineering Group, Inc Full time

Department: Field - USA Location: Greenville, NC START YOUR APPLICATION 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. We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position: Validation Engineer Job Description: 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. Qualifications: 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. START YOUR APPLICATION