Validation & Engineering Group

ATL01-121724 Validation Engineer Cold Room Qualification (NC)

Greenville, NC, US

Onsite
Full-time
5 months ago
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Summary

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: * Bachelors 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.

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