CQV Project/Program Manager

Mount Vernon, United States | Posted on 12/06/2025 Industry Pharma/Biotech/Clinical Research Job Type Full time Work Experience 5+ years State/Province Indiana Country United States Job Description Capital Project Management : Lead and manage full lifecycle of capital projects, including planning, budgeting, execution, and closeout, ensuring alignment with site and corporate goals. Technical Leadership: Oversee engineering activities for projects including, but not limited to: Facilities/Utilities supporting Oral Solid Dosage Manufacturing and Packaging, GMP processes, Automation upgrades, and QC Lab equipment. Budget & Financial Oversight: Develop and maintain accurate project budgets and forecasts; monitor project spend, track variances, and ensure financial accountability for capital expenditures. Documentation & Phase Deliverables: Ensure adherence to established project documentation, phase gates, and change management processes for technical and operational projects. Cross-Functional Collaboration : Partner with Manufacturing, Quality, Validation, and other cross-functional stakeholders to deliver integrated project outcomes and support site readiness for commercial and clinical operations. Vendor & Contractor Management: Manage external engineering firms, equipment vendors, and contractors to ensure adherence to project scope, quality, safety, and schedule requirements. Requirements Experience: 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. Technical Expertise: 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. Soft Skills: 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. Other: Willingness to work onsite at a GMP manufacturing facility Education Bachelor’s degree in Engineering (Mechanical, Chemical, Industrial, or related discipline). Advanced degree preferred. #J-18808-Ljbffr