Pharmatek · 1 month ago
CQV Project\/Program Manager
Mount Vernon, Indiana, United States
Full-time
Onsite
Senior Level
7+ years expPharmatek is a company in the Pharma/Biotech/Clinical Research industry, seeking a CQV Project/Program Manager. The role involves leading capital projects, overseeing engineering activities, managing budgets, and collaborating with cross-functional teams to ensure project success.
Information Technology & Services
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 spend, 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
Qualification
Required
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
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
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
Bachelor's degree in Engineering (Mechanical, Chemical, Industrial, or related discipline)
Preferred
Advanced degree preferred
Company
Pharmatek
Pharmatek provides Onsite consulting / Strategic Staff Aug services to Pharma & Life-sciences, Medical Devices Industry.
11-50 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase