QI
Engineering Project Manager (W2)
QvalFocus Inc.
West Chester Township · On-site Full-time Senior Yesterday
About the role
Responsibilities
- Lead CQV / Engineering capital projects across full lifecycle (scope, schedule, budget) in pharma/life sciences environments
- Manage multiple concurrent projects (filler, packaging, inspection systems, warehouse expansions, cold storage, VLMs, facility upgrades)
- Provide leadership in GMP-regulated environments aligned with CQV requirements
- Manage project budgets, forecasting, and cost control
- Execute CQV deliverables: commissioning plans, risk assessments, IQ/OQ/PQ validation
- Ensure project governance, change control, quality systems, and compliance readiness
- Collaborate with Engineering, Manufacturing, Quality, Validation, Supply Chain, EHS
- Manage vendors, contractors, and system integrators
- Oversee construction, installation, and field coordination
Requirements
- Bachelor’s degree in Engineering or related field
- 7–10+ years in pharma / biotech / life sciences
- Strong experience in CQV, capital project management
- Experience managing end-to-end capital projects (equipment/facility/warehouse systems)
- Knowledge of GMP, validation lifecycle, IQ/OQ/PQ
- Experience with warehouse systems (cold rooms, temperature-controlled storage, VLMs) – preferred
- Exposure to fill/finish, packaging, inspection systems, facility infrastructure
- Proficiency in Microsoft Project / scheduling tools
- Experience with budgeting, forecasting, cost control
- Strong leadership, communication, stakeholder management
- Ability to manage multiple priorities in fast-paced environments
- 100% onsite role – West Chester, OH
This role is strictly a W2 position.
Skills
GMPMicrosoft Project
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