CQV Project/Program Manager

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

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).
  

Project & Financial Skills:

• 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
  

• Bachelor’s degree in Engineering (Mechanical, Chemical, Industrial, or related discipline). Advanced degree preferred.