ATL01-121724 Validation Engineer Cold Room Qualification NC
ATL01-121724 Validation Engineer Cold Room Qualification NC
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Salary Not Disclosed
1 Vacancy
Job Description
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 28C) 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:
- Bachelors degree in Engineering Life Sciences or related field.
- 3 years of validation experience in GMPregulated 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.
Employment Type
Full Time
