CQV Resource

Stark Pharma Solutions Inc; Cary (NC); Presencial; USD 110.000 - 150.000; Jornada completa

Descripción de la vacante

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.

Formación

• 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.

Responsabilidades

• 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.

Conocimientos

CQV/Validation

Field verification

DeltaV OQ

P&ID verification

Documentation

Kneat

Smartsheet

MS Office

Teamwork

Troubleshooting

Herramientas

DeltaV

Kneat

Smartsheet

MS Office

Descripción del empleo

About The Company

Stark Pharma Solutions Inc. is a global consulting and staffing partner established in 2014, serving the Pharmaceutical, Medical Device, Biotech, and IT industries across the USA, Canada, and India. We provide specialized consulting and staffing solutions across Quality & Validation, Regulatory Affairs, R&D, Manufacturing, Supply Chain, Project Management, and IT, with a focus on delivering tailored solutions that drive growth, operational excellence, and long-term client success.

Position

CQV Resource

Location

North Carolina

Duration

Long Term

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.