Senior CQV Specialist – Pharma Manufacturing (DeltaV/OQ)

Stark Pharma Solutions Inc; Cary (NC); On-site; USD 110,000 - 150,000; Full time

Job summary

Stark Pharma Solutions Inc. is seeking a CQV Resource with 5+ years of experience in pharmaceutical facilities to lead commissioning and qualification activities.

The role covers upstream/downstream equipment, field verification of P&IDs, data sheets, and vendor drawings, plus system walkdowns and turnover packages. You will verify automation, perform OQ using DeltaV, and support projects with cross-functional teams in stainless-steel and large-molecule environments.

Qualifications

• 5+ years of CQV/Validation experience in pharma or life sciences facilities.
• Hands-on experience with upstream and/or downstream process equipment.
• Experience with DeltaV automation and OQ activities.
• Proficient in Kneat and Smartsheet for CQV documentation.

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.

Skills

CQV/Validation

Field verification

DeltaV OQ

P&ID verification

Documentation

Kneat

Smartsheet

MS Office

Teamwork

Troubleshooting

Tools

DeltaV

Kneat

Smartsheet

MS Office

Job description

Stark Pharma Solutions Inc. is seeking a CQV Resource with 5+ years of experience in pharmaceutical facilities to lead commissioning and qualification activities.

The role covers upstream/downstream equipment, field verification of P&IDs, data sheets, and vendor drawings, plus system walkdowns and turnover packages. You will verify automation, perform OQ using DeltaV, and support projects with cross-functional teams in stainless-steel and large-molecule environments.