CQV Project/Program Manager

Pharmatek Consulting

Mount Vernon, Indiana

JOB DETAILS
SKILLS
Automation, Biotech and Pharmaceutical, Budget Management, Budgeting, Capital Expenditure (CAPEX), Capital Project, Change Management, Communication Skills, Cross-Functional, Detail Oriented, Documentation, Drug Manufacturing, Engineering Management, Equipment Validation, Expense Tracking, Financial Management, Forecasting, GMP (Good Manufacturing Practices), Laboratory Equipment, Leadership, Maintain Compliance, Manufacturing, Mechanical Engineering, Microsoft Project, Multitasking, Organizational Skills, Process Validation, Project Lifecycle, Project Planning, Project Schedule, Project Tracking, Project/Program Management, Quality Control, Safety Training, Schedule Development, Supervisory Control and Data Acquisition (SCADA), Technical Leadership
LOCATION
Mount Vernon, Indiana
POSTED
14 days ago

KEY RESPONSIBILITIES
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Capital Project Management<\/b>: Lead and manage full lifecycle of capital projects, including planning, budgeting, execution, and closeout, ensuring alignment with site and corporate goals.
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Technical Leadership:<\/b> 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.
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Budget & Financial Oversight: <\/b>Develop and maintain accurate project budgets and forecasts; monitor project spend, track variances, and ensure financial accountability for capital expenditures.
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Documentation & Phase Deliverables:<\/b> Ensure adherence to established project documentation, phase gates, and change management processes for technical and operational projects.
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Cross -Functional Collaboration<\/b>: Partner with Manufacturing, Quality, Validation, and other cross -functional stakeholders to deliver integrated project outcomes and support site readiness for commercial and clinical operations.
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Vendor & Contractor Management:<\/b> Manage external engineering firms, equipment vendors, and contractors to ensure adherence to project scope, quality, safety, and schedule requirements
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Requirements<\/h3>

Experience:<\/span><\/span><\/b>
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  •  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.<\/span>
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  •  Proven track record in capital project management, managing multiple projects at once.<\/span>
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    Technical Expertise:<\/span><\/span><\/b>
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    • Strong understanding of Facilities/Utilities supporting Oral Solid Dosage Manufacturing and Packaging, GMP processes, Automation upgrades, and QC Lab equipment.<\/span>
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    • Knowledge of pharmaceutical packaging, modern controls and safety devices, tablet inspection systems, SCADA/PAS -X integrations, and equipment validation.<\/span>
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    •  Familiarity with process utilities and equipment qualification protocols (IQ/OQ/PQ).<\/span>
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      Project & Financial Skills:<\/span><\/span><\/b>
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      • Highly skilled utilizing Microsoft Project for schedule/project plan development.<\/span>
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      • Skilled in budgeting, forecasting, and cost control within complex, regulated environments.<\/span>
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        Soft Skills:<\/span><\/span><\/b>
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        • Strong leadership and communication skills, with the ability to influence cross -functional teams.<\/span>
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        •  Highly organized, detail -oriented, and capable of managing multiple priorities in a dynamic environment.<\/span>
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          Other:<\/span>
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          •  Willingness to work onsite at a GMP manufacturing facility<\/span>
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            Education: <\/span><\/span><\/b>
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            • Bachelor’s degree in Engineering (Mechanical, Chemical, Industrial, or related discipline). Advanced degree preferred.<\/span>
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About the Company

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Pharmatek Consulting