ATL01-121724 Validation Engineer – Cold Room Qualification

5 days ago

Greenville, North Carolina, United States Validation & Engineering Group Full time $90,000 - $120,000 per year

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.

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