Downstream CQV Engineer

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

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

Required Qualifications

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