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Katalyst HealthCares & Life Sciences
CQV Project Manager/Program Manager ConsultantKatalyst HealthCares & Life Sciences • Mount Vernon, IN
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CQV Project Manager/Program Manager Consultant

CQV Project Manager/Program Manager Consultant

Katalyst HealthCares & Life Sciences • Mount Vernon, IN
30+ days ago
Job type
  • Full-time
Job description


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 – 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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CQV Project Manager/Program Manager Consultant • Mount Vernon, IN

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