CQV Lead, Capital Projects (GMP Biopharma)

Veg Group; North Carolina; On-site; USD 120,000 - 180,000; Full time

Job summary

Pinnaql seeks an experienced Commissioning, Qualification & Validation (CQV) Lead to support GMP-regulated biopharmaceutical capital projects in North Carolina. The ideal candidate will guide CQV activities from design through turnover, ensuring compliance with GMP requirements, and on-time delivery of qualification packages.

You will lead technical teams, manage schedules and vendors, review P&IDs and equipment specs, and collaborate across Engineering, QA, Manufacturing, and Operations to

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or related technical discipline.
• 8–10+ years of experience in Commissioning, Qualification, and Validation within GMP-regulated pharmaceutical or biotechnology manufacturing.
• Demonstrated experience leading CQV execution for capital projects, including 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.
• Proven ability to lead technical teams, manage contractors, and coordinate multiple projects simultaneously.
• 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, system turnover, and operational handover.
• Develop, review, and approve CQV plans, protocols, reports, risk assessments, and supporting documentation.
• Oversee commissioning and qualification of manufacturing equipment, process systems, clean utilities, and facility infrastructure.
• Coordinate and oversee FAT, SAT, IQ, OQ, and PQ activities, as applicable.
• Manage CQV execution schedules, deliverables, resources, and priorities to support capital project milestones.
• Provide technical leadership and direction to CQV engineers, validation specialists, contractors, and vendors.
• Collaborate with Capital Projects, Engineering, Automation, Quality Assurance, Manufacturing, and Operations.
• Review technical documentation, including P&IDs, equipment specifications, design drawings, and vendor documentation.
• Lead resolution of commissioning and qualification discrepancies, deviations, and change controls.
• Ensure CQV documentation meets GMP requirements, applicable regulatory standards, and established site procedures.
• Track project progress, identify risks, implement mitigation plans, and communicate status to stakeholders.
• Ensure timely completion of qualification packages, system turnover, and readiness for GMP operations.

Skills

CQV leadership

GMP compliance

Project management

Regulatory knowledge

Team leadership

Documentation

Education

Bachelor's degree in Engineering

Life Sciences background

Tools

P&ID reviews

Job description

Pinnaql seeks an experienced Commissioning, Qualification & Validation (CQV) Lead to support GMP-regulated biopharmaceutical capital projects in North Carolina. The ideal candidate will guide CQV activities from design through turnover, ensuring compliance with GMP requirements, and on-time delivery of qualification packages.

You will lead technical teams, manage schedules and vendors, review P&IDs and equipment specs, and collaborate across Engineering, QA, Manufacturing, and Operations to