The Factory Project Manager will lead the end-to-end development of a new EU-GMP sterile injectable pharmaceutical manufacturing facility, from project planning and facility design through construction, equipment installation, commissioning, qualification, validation, and GMP readiness.

Key Responsibilities

Project Leadership & Governance

• Lead the greenfield project strategy, scope, timeline, budget, and execution, reporting progress, risks, and key decisions to the Executive Board.
• Coordinate cross-functional teams and drive project delivery across all workstreams.

Facility Design & GMP Planning

• Lead GMP facility design, layout, cleanroom zoning, personnel/material flows, and contamination-control strategy.
• Review URS, specifications, technical drawings, and engineering solutions to ensure GMP compliance.

Construction & Project Execution

• Oversee construction, installation, testing, commissioning, and facility handover.
• Manage EPC contractors, consultants, vendors, and project milestones to ensure quality, cost, and schedule compliance.

Production & Process Equipment

• Lead the selection, procurement, installation, commissioning, and qualification of sterile manufacturing equipment
• Ensure process equipment is properly integrated with facility and utility systems and meets GMP requirements.

Engineering & Utility Systems

• Oversee HVAC, cleanrooms, pharmaceutical water/WFI, compressed air, steam, electrical, instrumentation, and process systems.
• Lead engineering design, URS, P&IDs, maintenance, calibration, and documentation for GMP-compliant, qualified systems.

Qualification, Validation & GMP Readiness

• Lead commissioning & qualification (C&Q), validation, and GMP readiness across facility, utilities, equipment, and critical systems.
• Ensure documentation, deviations/CAPA, and regulatory inspection readiness are completed.

Project Procurement, Budget & Risk Management

• Manage CAPEX, procurement, contracts, vendors, critical equipment delivery, and project costs.
• Identify and mitigate key technical, regulatory, commercial, and execution risks.

Operational Readiness & Handover

• Drive operational readiness and plant handover, covering SOPs, maintenance, calibration, technical documentation, and team readiness.
• Ensure the facility is ready for GMP-compliant manufacturing operations.

Requirements

Education

• Bachelor’s degree or above in Engineering or a related field.

Experience

• 10+ years in pharmaceutical engineering, manufacturing, or plant projects.
• Proven track record in end-to-end greenfield sterile injectable projects (EU-GMP).
• Experience leading EPC contractors, consultants, vendors, and multidisciplinary teams.

Skills

• GMP facility, cleanroom, HVAC, utilities, and qualification/validation expertise.
• CAPEX, project planning, vendor, and risk management.
• Project leadership, stakeholder management, and English communication.