0017V6037 CQV Project Manager/Program Manager Consultant (Pharma)

0017V6037 CQV Project Manager/Program Manager Consultant (Pharma)
Please contact Amanda Mazza, amanda@tworivercp.com

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.
 QUALIFICATIONS & REQUIREMENTSEducation:
Bachelor’s degree in Engineering (Mechanical, Chemical, Industrial, or related discipline). Advanced degree preferred.
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

LOCATION
On-site in Mount Vernon, IN

EMPLOYMENT
Competitive C2C or W2 Contractor – 1+ year assignment, potential to go longer
 

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