ATL01-121724 Validation Engineer � Cold Room Qualification (NC)

Validation & Engineering Group • Greenville, NC

1d

About The Position

We are seeking a skilled Validation Engineer to perform the full qualification of a cold room (2-8C) for a regulated FDA production site. The engineer will be responsible for executing qualification protocols, ensuring compliance with GMP standards, and delivering comprehensive documentation.

Requirements

• 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.

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 101-250 employees