CAPITAL PROJECT MANAGER

Job Summary

The Capital Project Manager – Pharmaceutical Manufacturing  is responsible for leading the planning, execution, and successful delivery of capital expansion projects within a pharmaceutical manufacturing facility. This position manages projects from initial concept and feasibility through design, construction, commissioning, qualification, validation, and final handover to operations. 

Key Responsibilities

Capital Project Leadership

• Lead multiple capital expansion projects ranging from facility modifications and infrastructure improvements to new manufacturing areas, production lines, utilities, and support systems.
• Develop project scope, objectives, schedules, budgets, resource requirements, and execution strategies.
• Establish project governance, milestones, deliverables, and performance metrics.
• Manage projects through the full lifecycle, including feasibility, conceptual design, detailed design, procurement, construction, commissioning, qualification, validation, and closeout.

Engineering, Design & Construction

• Coordinate engineering and design activities with internal engineering teams, consultants, architects, equipment vendors, and contractors.
• Review and approve project designs, specifications, layouts, equipment selections, and construction plans.
• Ensure designs meet applicable pharmaceutical, GMP, facility, process, safety, and engineering standards.
• Manage construction activities while maintaining a strong focus on safety, quality, schedule, and minimizing disruption to ongoing manufacturing operations.
• Coordinate shutdowns, tie-ins, equipment installations, facility modifications, and other work requiring interaction with operating production areas.

GMP, Quality & Validation

• Ensure capital projects are executed in compliance with applicable FDA, cGMP, OSHA, environmental, and company requirements.
• Partner with Quality Assurance and Validation teams to establish project-specific qualification and validation strategies.
• Ensure appropriate documentation is generated and maintained throughout the project lifecycle.
• Support or oversee URS, risk assessments, design reviews, FAT, SAT, commissioning, IQ/OQ/PQ, and validation activities, as applicable.
• Ensure project changes are appropriately managed through established change-control processes.
• Support regulatory inspections and audits by ensuring project documentation and facility changes are properly documented and compliant.

Required Qualifications

• Bachelor's degree in Engineering, Construction Management, Project Management, or a related technical discipline.
• 7+ years of experience managing capital projects, preferably within pharmaceutical, biotechnology, medical device, chemical, or other regulated manufacturing environments.
• Demonstrated experience managing projects involving facility expansion, manufacturing equipment, process systems, utilities, or infrastructure.
• Experience managing projects from concept through construction, commissioning, qualification, and operational handover.
• Strong understanding of GMP requirements and regulated manufacturing environments.
• Demonstrated ability to manage project budgets, schedules, contractors, consultants, and multiple concurrent workstreams.
• Strong understanding of engineering, construction, commissioning, and qualification processes.
• Excellent written, verbal, organizational, and interpersonal communication skills.