What are the responsibilities and job description for the CQV Project Manager/Program Manager Consultant position at Katalyst CRO?
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.
- Bachelor's degree in engineering (Mechanical, Chemical, Industrial, or related discipline). Advanced degree preferred.
- Minimum 710 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.
- 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.