CQV Lead, Capital Projects for GMP Biopharma

Validation & Engineering Group, Inc.

United States

On-site

USD 150,000 - 190,000

Full time

46 hours ago

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Job summary

Pinnaql is seeking an experienced CQV Lead to support capital projects at a GMP-regulated biopharmaceutical manufacturing facility in North Carolina. The ideal candidate will lead CQV activities for capital equipment, process systems, utilities, and facility infrastructure, ensuring GMP compliance, project deliverables, and execution schedules.

Previous CQV experience on capital projects is highly preferred.

Qualifications

Bachelor's degree in Engineering or Life Sciences.
8–10+ years in Commissioning, Qualification, and Validation within GMP-regulated pharma/biotech manufacturing.
Proven experience leading CQV execution for capital projects, including equipment installations and facility upgrades.

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 project milestones.
Provide technical leadership to CQV engineers, validation specialists, contractors, and vendors.
Collaborate with Capital Projects, Engineering, QA, Manufacturing, and Operations.