CQV Engineer
Job Title: CQV Engineer
Location: Summit, NJ (Onsite local candidates only )
Duration: 6 Months to 2 Years (Long-Term Contract)
About the Role:
We re hiring a Validation/CQV Engineer with strong experience in Controlled Temperature Units (CTUs) and hands-on use of Ellab equipment. You ll be supporting critical CQV activities for pharmaceutical and biotech facilities, ensuring compliance in a regulated GMP environment.
About the Client:
Our client delivers specialized GxP and CQV services across pharma, biotech, cell therapy, and medical device sectors. Their core focus includes equipment and facility commissioning, qualification, validation, and CTU/cold-storage temperature mapping.
Key Responsibilities:
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Execute and document commissioning, qualification, and validation protocols
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Perform CTU temperature mapping and related validation tasks
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Operate and troubleshoot Ellab data logging systems
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Review technical data and generate clear, compliant reports
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Ensure activities meet GMP and regulatory standards
Required Qualifications:
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4 6 years of hands-on CQV experience in pharma or biotech facilities
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Proven expertise in CTU and cold-storage temperature mapping
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Mandatory experience using Ellab equipment
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Strong grasp of regulatory compliance and GMP guidelines
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Ability to work onsite in Summit, NJ local candidates preferred
Bonus if you have:
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Experience with cell therapy or aseptic environments
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Familiarity with validation lifecycle documentation (URS, IQ/OQ/PQ)
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