CQV Engineer

GxP Associates; North Carolina; On-site; USD 110,000 - 160,000; Full time

Job summary

GxP Associates seeks an experienced CQV Engineer to lead commissioning, qualification, and validation of biopharmaceutical manufacturing systems in a GMP setting. You will work with Engineering, Automation, Manufacturing, Quality, and Validation teams to ensure robust system readiness and compliant documentation.

The role emphasizes hands-on qualification of bioprocess equipment, with DeltaV controls and fast problem solving, in a regulated plant environment in North Carolina.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, Biotechnology, or related field.
• 5+ years hands-on CQV, commissioning, qualification, validation, or process engineering in pharma.
• Experience in GMP-regulated manufacturing and biopharma environments.
• Hands-on qualification of bioprocess equipment and systems.

Responsibilities

• Execute CQV activities for GMP biopharmaceutical manufacturing systems and equipment.
• Perform system walkdowns to verify installation, piping, instrumentation, utilities and configuration.
• Support commissioning activities including startup, checks, testing and troubleshooting.
• Develop IQ/OQ/PQ protocols and qualification documentation per procedures.
• Support qualification of bioreactors, UF/UFDF skids, chromatography, viral filtration, hold tanks.
• Review equipment specs, P&IDs, vendor docs, and engineering deliverables.
• Coordinate FAT/SAT, turnover, readiness, and integration with Automation teams.
• Verify DeltaV-controlled equipment and systems; validate alarms, interlocks, and controls.
• Ensure CQV activities comply with GMP, GxP, FDA, and data integrity principles.

Skills

GMP compliance

CQV/Qualification

Documentation

Process equipment

Education

Bachelor's degree in Engineering/Life Sciences/Biotech

Tools

DeltaV

Job description

We are seeking an experienced CQV (Commissioning, Qualification & Validation) Engineer with 5+ years of experience supporting commissioning, qualification, and validation activities within GMP-regulated pharmaceutical or biopharmaceutical manufacturing environments. The ideal candidate will have strong hands-on experience with process equipment and systems, including bioreactors, pumps, centrifuges, UF/UFDF skids, chromatography systems, viral filtration systems, buffer preparation systems, and hold tanks.

The CQV Engineer will be responsible for executing commissioning and qualification activities from system walkdowns through final documentation, while working closely with Engineering, Automation, Manufacturing, Quality, and Validation teams. Experience with DeltaV process control systems and automated manufacturing equipment is highly preferred.

Key Responsibilities

Execute Commissioning, Qualification, and Validation (CQV) activities for GMP biopharmaceutical manufacturing systems and process equipment.

Perform detailed systems walkdowns to verify equipment installation, piping, instrumentation, utilities, components, and system configuration against approved engineering documentation and P&IDs.

Support commissioning activities including equipment startup, functional checks, loop checks, operational testing, and troubleshooting.

Develop and execute IQ, OQ, PQ, commissioning protocols, test scripts, and qualification documentation in accordance with approved procedures.

Support qualification of bioreactors, pumps, centrifuges, UF/UFDF skids, chromatography systems, viral filtration systems, buffer preparation systems, and process hold tanks.

Review and verify equipment specifications, P&IDs, equipment drawings, vendor documentation, and engineering deliverables.

Support FAT/SAT activities, equipment turnover, commissioning readiness, and qualification readiness.

Work with Automation/Controls teams to support qualification and testing of DeltaV-controlled process equipment and systems.

Execute functional and operational testing of automated equipment, including verification of alarms, interlocks, sequences, recipes, controls, and process parameters.

Support DeltaV system testing and integration activities associated with bioprocess equipment and manufacturing systems.

Identify installation, functional, and documentation discrepancies during systems walkdowns and coordinate resolution with Engineering and project teams.

Generate and manage punch lists, discrepancies, deviations, change controls, and corrective actions associated with CQV activities.

Review vendor turnover packages, equipment manuals, calibration records, certificates, and other commissioning/qualification documentation.

Ensure qualification activities are performed in compliance with GMP, GxP, FDA requirements, data integrity principles, and site validation procedures.

Maintain accurate and complete CQV documentation and ensure testing is executed in accordance with approved protocols.

Collaborate with Process Engineering, Manufacturing, Automation, Quality Assurance, Facilities, and Maintenance teams to resolve technical issues and maintain project schedules.

Participate in project meetings, readiness reviews, system handovers, and commissioning/qualification planning activities.

Support preparation and execution of Commissioning Plans, Validation Plans, System Impact Assessments, Risk Assessments, and qualification strategies.

Ensure all CQV deliverables are completed on schedule and meet project and regulatory requirements.

Required Qualifications

Bachelor's degree in Engineering, Life Sciences, Biotechnology, or a related technical discipline.

5+ years of hands-on CQV, Commissioning, Qualification, Validation, or Process Engineering experience within pharmaceutical or biopharmaceutical manufacturing.

Strong experience working in GMP-regulated manufacturing environments.

Hands-on experience qualifying and commissioning bioprocess equipment and systems.

Preferred Qualifications

Experience supporting greenfield or facility expansion projects in biopharmaceutical manufacturing.

Experience with single-use and stainless-steel bioprocess systems.

Experience supporting FAT, SAT, commissioning, turnover, and qualification execution.

Familiarity with GAMP 5, 21 CFR Part 11, ALCOA+, and data integrity principles.