CQV Resource

Job Overview: We are seeking a CQV Resource with 5+ years of experience in pharmaceutical or life sciences facilities. The ideal candidate will have hands-on experience with commissioning and qualification of upstream and/or downstream process equipment, field verification, system walkdowns, and DeltaV-based OQ activities.

Key Responsibilities: Perform field verification of P&IDs, equipment datasheets, vendor drawings, isometrics, and utility connections. Verify equipment and systems against approved designs and as-built conditions. Perform system completion walkdowns and turnover package reviews. Review punch lists, weld documentation, calibration records, redlines, and construction readiness. Execute CQV activities for upstream equipment including bioreactors, media preparation systems, incubators, pumps, and centrifuges. Execute CQV activities for downstream equipment including chromatography skids, UF/DF systems, viral filtration, depth filtration, buffer preparation, and product hold tanks. Perform startup and testing activities for chromatography systems. Verify flow paths, valve sequencing, conductivity, pressure monitoring, and automation functionality. Perform loop checks, I/O verification, alarm testing, interlock testing, and control logic verification. Execute OQ activities for automated systems using DeltaV. Identify and resolve startup issues related to automation logic, valve sequencing, cleaning cycles, and equipment interfaces. Support commissioning and qualification activities in stainless-steel and large-molecule manufacturing environments. Use Kneat, Smartsheet, and Microsoft Office for CQV documentation, tracking, and project activities. Work with engineering, automation, construction, validation, and operations teams to support project completion.

Required Qualifications: 5+ years of relevant CQV/Validation experience in pharmaceutical or life sciences facilities. Hands-on experience with large-scale pharma or biotech manufacturing facilities. Experience with upstream and/or downstream process equipment. Experience in stainless-steel and large-molecule manufacturing environments. Experience with equipment such as bioreactors, pumps, centrifuges, UF/DF skids, chromatography systems, viral filtration systems, and buffer/hold tanks. Strong experience performing field verification of P&IDs, equipment datasheets, vendor drawings, and related documentation. Experience with system walkdowns, turnover package reviews, punch list reviews, calibration records, and redlines. Experience executing OQ activities for automated systems using DeltaV. Experience testing alarms, interlocks, I/O, loops, valve sequences, and automation logic. Experience identifying and resolving startup and commissioning issues. Process engineering experience in upstream or downstream operations is a plus. Brownfield or existing facility experience is a plus. Experience with Kneat and Smartsheet is a plus. Strong working knowledge of Microsoft Office. Strong documentation, communication, troubleshooting, and teamwork skills. Stark Pharma is an Equal Opportunity Employer and welcomes qualified candidates from diverse backgrounds.