Downstream CQV Engineer

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.