Downstream CQV Engineer

Job Description

Job Summary

We are seeking experienced Downstream CQV Engineers to support a large-scale biopharmaceutical manufacturing project in North Carolina. The ideal candidates will have hands-on experience executing Commissioning, Qualification, and Validation (CQV) activities for downstream manufacturing equipment and systems within a GMP-regulated biopharmaceutical environment .

Candidates must be able to clearly demonstrate the specific downstream equipment and systems they have personally supported through qualification and CQV execution.

Key Responsibilities

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• Execute Commissioning, Qualification, and Validation (CQV) activities for downstream biopharmaceutical manufacturing equipment and systems.
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• Develop, review, and execute IQ/OQ protocols , qualification documents, test scripts, and supporting CQV documentation.
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• Support equipment and system turnover from Construction to CQV .
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• Participate in Mechanical Completion (MC/MCC) activities and system energization.
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• Review construction and turnover documentation to confirm systems are ready for CQV execution.
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• Perform field execution of qualification protocols and document test results in accordance with approved procedures.
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• Support identification, documentation, and resolution of CQV issues, discrepancies, and challenges .
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• Work closely with Engineering, Construction, Automation, Manufacturing, Quality, and Project teams to resolve qualification-related issues.
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• Review equipment specifications, drawings, P&IDs, vendor documentation, and turnover packages as required.
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• Support equipment start-up, commissioning, and qualification activities in an active GMP manufacturing environment.
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• Ensure CQV activities are performed in compliance with GMP, SOPs, validation procedures, and project requirements .
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• Support investigation and resolution of protocol deviations and qualification discrepancies.
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• Maintain accurate and complete qualification documentation and execution records.
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• Communicate project status, field issues, and qualification progress to project leadership and cross-functional stakeholders.
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Required Qualifications

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• 2–4+ years of hands-on downstream equipment qualification/CQV experience in a pharmaceutical or biopharmaceutical manufacturing environment.
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• Direct experience executing IQ/OQ and equipment qualification activities .
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• Experience working in a GMP-regulated manufacturing environment .
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• Experience with Construction-to-CQV turnover processes.
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• Hands-on experience with Mechanical Completion (MC/MCC) and system energization activities.
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• Ability to troubleshoot and resolve field-level CQV and qualification challenges .
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• Strong understanding of commissioning and qualification lifecycle activities.
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• Ability to review and execute technical qualification documentation accurately.
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• Strong communication and documentation skills.
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• Ability and willingness to work full-time onsite in North Carolina .
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