- CQV Lead, Capital Projects
Position Summary
Pinnaql is seeking an experienced Commissioning, Qualification & Validation (CQV) Lead to support capital projects at a GMP-regulated biopharmaceutical manufacturing facility in North Carolina.
The ideal candidate will have extensive experience leading CQV activities for capital equipment, manufacturing systems, utilities, and facility infrastructure, ensuring compliance with GMP requirements, project deliverables, and execution schedules.
Previous experience with capital projects, engineering standards, and CQV procedures is highly preferred.
Key Responsibilities
- Lead CQV activities for capital projects from design review and commissioning 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.
Required Qualifications
- Bachelor's degree in Engineering, Life Sciences, or a 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.
- Strong technical documentation, troubleshooting, communication, and stakeholder management skills.
- Ability to work on-site in North Carolina.
Preferred Qualifications
- Experience supporting large-scale biologics manufacturing or fill-finish operations.
- Experience with greenfield or brownfield capital projects.
- Familiarity with ASTM E2500, ISPE Baseline Guides, and risk-based commissioning and qualification approaches.
- Experience managing multidisciplinary CQV teams and external service providers.
- PMP certification or equivalent project leadership experience.
Ideal Candidate Profile
- A proactive, hands-on CQV leader capable of independently managing commissioning and qualification workstreams, leading technical teams, resolving execution challenges, and ensuring capital projects meet quality, compliance, and schedule expectations.
- Candidates with previous Amgen experience and a proven track record delivering CQV activities for capital projects are strongly preferred.
