Senior CQV Lead for GMP Capital Projects

Pinnaql, Inc.; North Carolina; Hybrid; USD 120,000 - 180,000; Full time

Job summary

Pinnaql, Inc. seeks an experienced CQV Lead to support capital projects at a GMP-biopharma facility in North Carolina.

You will lead CQV activities for equipment, systems, utilities, and facility infrastructure, ensuring GMP compliance and on-time delivery. The ideal candidate has 8–10+ years in CQV within GMP manufacturing, with strong leadership, documentation, and regulatory knowledge, and the ability to work on-site in North Carolina.

Qualifications

• 8–10+ years in Commissioning, Qualification, and Validation within GMP-regulated pharmaceutical or biotechnology manufacturing.
• Experience leading CQV execution for capital projects (equipment installations, facility expansions, or manufacturing upgrades).
• Strong knowledge of FAT, SAT, IQ, OQ, PQ, and risk-based qualification methodologies.
• Experience qualifying manufacturing equipment, process systems, critical utilities, and facility infrastructure.
• Knowledge of FDA regulations, cGMP requirements, and industry commissioning and qualification practices.
• Ability to work on-site in North Carolina.

Responsibilities

• Lead CQV activities for capital projects from design review through qualification and handover.
• Develop, review, and approve CQV plans, protocols, reports, risk assessments, and supporting documentation.
• Oversee commissioning and qualification of manufacturing equipment, process systems, utilities, and facility infrastructure.
• Coordinate FAT, SAT, IQ, OQ, and PQ activities as applicable.
• Manage CQV execution schedules, deliverables, resources, and priorities to meet milestones.
• Provide technical leadership to CQV engineers, validation specialists, contractors, and vendors.
• Collaborate with Capital Projects, Engineering, Automation, QA, Manufacturing, and Operations.
• Review technical documentation (P&IDs, equipment specs, drawings, vendor docs).
• Lead resolution of CQV discrepancies, deviations, and change controls.
• Ensure CQV docs meet GMP and site procedures; track progress and risks.

Skills

CQV leadership

Regulatory knowledge

Project leadership

Documentation

Troubleshooting

Stakeholder management

Education

Bachelor's degree in Engineering

Bachelor's degree in Life Sciences

Job description

Pinnaql, Inc. seeks an experienced CQV Lead to support capital projects at a GMP-biopharma facility in North Carolina.

You will lead CQV activities for equipment, systems, utilities, and facility infrastructure, ensuring GMP compliance and on-time delivery. The ideal candidate has 8–10+ years in CQV within GMP manufacturing, with strong leadership, documentation, and regulatory knowledge, and the ability to work on-site in North Carolina.