CQV Lead, Capital Projects

Pinnaql; North Carolina; Ibrido; USD 120.000 - 180.000; Tempo pieno

Descrizione del lavoro

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.

Competenze

• 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.

Mansioni

• 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.

Conoscenze

CQV leadership

Regulatory knowledge

Project leadership

Documentation

Troubleshooting

Stakeholder management

Formazione

Bachelor's degree in Engineering

Bachelor's degree in Life Sciences

Descrizione del lavoro

Pinnaql is a trusted consulting partner to regulated life sciences companies, providing deep technical, validation, and quality expertise across every stage of the product lifecycle. We partner with pharmaceutical, biotech, and medical device organizations to navigate complexity, accelerate project timelines, and maintain a strong state of compliance and audit readiness.

We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:

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.

At Pinnaql, people always come first. We believe that when you're empowered to do your best work, bold ideas thrive and real progress happens. This isn't just a job - it's an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose-driven, supportive team.

Excited to build something meaningful together? We look forward to hearing from you.

Pinnaql is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.