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
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