CQV Project/Program Manager
On-siteMount Vernon Wabash County, Indiana, United States
Job Summary
Lead and manage the full lifecycle of capital projects, including planning, budgeting, execution, and closeout, ensuring alignment with site and corporate goals. Oversee engineering activities for facilities, utilities, GMP processes, automation upgrades, and QC lab equipment while developing accurate project budgets and forecasts. Monitor project spend, track variances, and ensure financial accountability for capital expenditures. Partner with Manufacturing, Quality, Validation, and other cross-functional stakeholders to deliver integrated outcomes and support site readiness. Manage external engineering firms, equipment vendors, and contractors to ensure adherence to project scope, quality, safety, and schedule requirements. Ensure adherence to established project documentation, phase gates, and change management processes. Requires 7–10 years of pharmaceutical manufacturing experience, onsite presence at a GMP facility, and proficiency in Microsoft Project.
Required Qualifications
- Minimum 7–10 years of experience in pharmaceutical manufacturing with a focus on Oral Solid Dosage Manufacturing and Packaging, GMP processes, Automation upgrades, and QC Lab equipment.
- Proven track record in capital project management, managing multiple projects at once.
- Strong understanding of Facilities/Utilities supporting Oral Solid Dosage Manufacturing and Packaging, GMP processes, Automation upgrades, and QC Lab equipment.
- Knowledge of pharmaceutical packaging, modern controls and safety devices, tablet inspection systems, SCADA/PAS-X integrations, and equipment validation.
- Familiarity with process utilities and equipment qualification protocols (IQ/OQ/PQ).
- Highly skilled utilizing Microsoft Project for schedule/project plan development.
- Skilled in budgeting, forecasting, and cost control within complex, regulated environments.
- Strong leadership and communication skills, with the ability to influence cross-functional teams.
- Highly organized, detail-oriented, and capable of managing multiple priorities in a dynamic environment.
- Willingness to work onsite at a GMP manufacturing facility
- Bachelor's degree in Engineering (Mechanical, Chemical, Industrial, or related discipline).
Desired Qualifications
- Advanced degree
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