CQV Lead, Capital Projects — GMP, On‑Site NC

Validation & Engineering Group; North Carolina; Remote; USD 120,000 - 180,000; Full time

Job summary

Pinnaql is seeking an experienced Commissioning, Qualification & Validation (CQV) Lead to support capital projects at a GMP-regulated biopharmaceutical facility in North Carolina.

The ideal candidate will have extensive experience leading CQV activities for capital equipment, manufacturing systems, utilities, and facility infrastructure, ensuring GMP compliance, project deliverables, and execution schedules.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or related technical discipline.
• 8–10+ years in commissioning, qualification, and validation within GMP-regulated pharma/biotech manufacturing.
• Experience leading CQV execution for capital projects (equipment installations, facility expansions, or upgrades).
• Strong knowledge of FAT, SAT, IQ, OQ, PQ and risk-based qualification.
• Proven ability to lead technical teams, manage contractors, and coordinate multiple projects.

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 documentation.
• Oversee commissioning and qualification of manufacturing equipment, process systems, utilities, and facility infrastructure.
• Coordinate FAT, SAT, IQ, OQ, PQ activities as applicable.
• Manage CQV execution schedules, 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 docs including P&IDs, specs, drawings, and vendor docs.
• Lead resolution of CQV discrepancies, deviations, and change controls.
• Ensure CQV docs meet GMP requirements and regulatory standards.
• Track progress, identify risks, and communicate status to stakeholders.
• Ensure timely completion of qualification packages and system turnover.

Skills

CQV leadership

GMP knowledge

Project management

Regulatory knowledge

On-site collaboration

Education

Bachelor's degree in Engineering/Life Sciences

Job description

Pinnaql is seeking an experienced Commissioning, Qualification & Validation (CQV) Lead to support capital projects at a GMP-regulated biopharmaceutical facility in North Carolina.

The ideal candidate will have extensive experience leading CQV activities for capital equipment, manufacturing systems, utilities, and facility infrastructure, ensuring GMP compliance, project deliverables, and execution schedules.