Validation & Engineering Group, Inc. · 4 weeks ago
ATL01-121724 Validation Engineer – Cold Room Qualification (NC)
Greenville, NC
Full-time
Onsite
Mid Level
3+ years expValidation & Engineering Group, Inc. is a leading services supplier providing solutions for various industries including Pharmaceuticals and Biotechnology. They are seeking a skilled Validation Engineer to perform the full qualification of a cold room for a regulated FDA production site, ensuring compliance with GMP standards and delivering comprehensive documentation.
BiotechnologyConsultingProfessional ServicesQuality Assurance
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
Qualification
Required
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
Company
Validation & Engineering Group, Inc.
Validation & Engineering Group, Proudly serving our clients since 1997.
51-200 employees
Funding
Current Stage
Growth StageTotal Funding
unknown2025-08-06Acquired
Leadership Team
Luis Puig
Partner
Recent News
News is my Business
2025-08-20
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