Logo
Veg Group

ATL01-121724 Validation Engineer Cold Room Qualification (NC)

Veg Group, Raleigh, North Carolina, United States

Save Job

Career Opportunities with Validation & Engineering Group

A great place to work.

Current job opportunities are posted here as they become available.

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.

#J-18808-Ljbffr