CQV Project/Program Manager

Pharmatek Consulting • Mount Vernon, IN

6d • Onsite

About The Position

KEY RESPONSIBILITIES 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

• 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

Responsibilities

• Lead and manage full lifecycle of capital projects, including planning, budgeting, execution, and closeout, ensuring alignment with site and corporate goals.
• 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.
• Develop and maintain accurate project budgets and forecasts; monitor project spend, track variances, and ensure financial accountability for capital expenditures.
• Ensure adherence to established project documentation, phase gates, and change management processes for technical and operational projects.
• Partner with Manufacturing, Quality, Validation, and other cross -functional stakeholders to deliver integrated project outcomes and support site readiness for commercial and clinical operations.
• Manage external engineering firms, equipment vendors, and contractors to ensure adherence to project scope, quality, safety, and schedule requirements

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level