Two River Consulting Partners

Project 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:
  Lead and oversee multi-disciplinary pharmaceutical manufacturing engineering projects, including equipment upgrades, site-wide system modernizations, utility and infrastructure improvements, and facility security enhancements, ensuring compliance with GMP requirements, validated system expectations, and operational reliability standards
• 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 & Requirements

• Education:
  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 CQV Engineering projects/upgrades, GMP processes, equipment qualification
  • Proven track record in capital project management, managing multiple projects at once
  • Construction experience
• Technical Expertise:
  • Strong understanding of multi-disciplinary pharmaceutical manufacturing engineering projects, including equipment upgrades, site-wide system modernizations, utility and infrastructure improvements, and facility security enhancements, ensuring compliance with GMP requirements, validated system expectations, and operational reliability standards
  • Knowledge of pharmaceutical packaging, modern controls and safety devices, 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