Capex Project Manager

Description:

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.