CQV Project Manager/Program Manager Consultant

Katalyst Healthcares and Life Sciences

Mount Vernon, IL

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 spends, 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.

Requirements:

Bachelor's degree in engineering (Mechanical, Chemical, Industrial, or related discipline). Advanced degree preferred.
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/Client-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.

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Vacancy posted 3 days ago

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