CAPITAL PROJECT MANAGER

Capital Project ManagerThe 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 ResponsibilitiesCapital Project LeadershipLead 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 & ConstructionCoordinate 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 & ValidationEnsure 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 QualificationsBachelor'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.