Job Details

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.