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

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.

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.