CAPEX Project Manager – Equipment Upgrade + Filling Line Upgrade
Long-term Contract opportunity
Role Overview
* Lead the end‑to‑end execution of equipment upgrade projects within a GMP pharmaceutical manufacturing environment.
* Ensure project delivery on time, within budget, and in compliance with regulatory and quality requirements.
Key Responsibilities
* Manage full project lifecycle: concept, design, procurement, installation, commissioning, and qualification (IQ/OQ/PQ).
* Develop and manage project scope, URS, timelines, budgets, and resource plans.
* Lead vendor selection, contract negotiations, and performance oversight.
* Coordinate cross‑functional teams including Engineering, Validation, QA, Manufacturing, Supply Chain, and EHS.
* Ensure compliance with GMP, FDA, EMA, and site quality systems throughout project execution.
* Oversee FAT/SAT activities, equipment integration, and technology transfer as required.
* Drive risk assessments, change control, and deviation management processes.
* Prepare and present project status reports, CAPEX forecasts, and progress updates to senior leadership.
* Ensure safe project execution following site EHS standards and engineering best practices.
Essential Experience
* Proven experience managing CAPEX projects in a pharmaceutical or biotech setting.
* Strong background with sterile manufacturing, lyophilization systems, aseptic processing equipment, or Filling equipment.
* Demonstrated delivery of equipment upgrade or installation projects within regulated environments.
* Solid understanding of validation, commissioning, and qualification principles.
* Experience with vendor management and engineering project documentation.
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