The Capital Project Manager is responsible for the endtoend delivery of capital projects within a GMP-regulated manufacturing environment, from project initiation through commissioning, qualification, and handover. This role requires hands-on construction management capability, strong crossfunctional leadership, and demonstrated experience delivering manufacturing, utilities, and infrastructure projects in compliance with GMP, quality, and regulatory requirements.
The Project Manager is accountable for scope, schedule, cost, quality, safety, and risk, and serves as the primary interface between Engineering, Construction, Quality, Validation, Operations, and external partners.
Capital Project Manager Responsibilities:
Project Leadership & Governance
- Lead capital projects in accordance with enterprise capital governance and phasegate requirements
- Act as single point of accountability for project execution, decision-making, and escalation
- Align project objectives with business needs, operational readiness, and regulatory expectations
- Provide clear and proactive communication to senior leadership and stakeholders
Scope, Cost & Schedule Management
- Define and manage project scope, ensuring alignment with approved business requirements
- Develop, maintain, and control integrated cost and schedule baselines
- Lead change management, trend analysis, and forecastatcompletion reporting
- Ensure timely identification and mitigation of project risks and constraints
Design & Engineering Oversight (GMP Environment)
- Oversee development and approval of URS, Basis of Design, specifications, and drawings
- Ensure GMP design principles are embedded (material/personnel flow, segregation, cleanability)
- Facilitate GMP and constructability design reviews with Quality and Operations
- Ensure documentation supports validation, regulatory inspection, and lifecycle management
Construction Management
- Lead construction planning and execution, including site logistics, sequencing, and safety
- Manage contractors, CM firms, and vendors to ensure efficient and compliant delivery
- Oversee daily/weekly construction progress, field change control, and issue resolution
- Enforce GMP construction controls: segregation, cleanliness, and controlled turnover
Commissioning, Qualification & Validation
- Ensure structured system turnover from construction to commissioning
- Coordinate commissioning activities to support qualification readiness
- Partner with Validation and Quality to support IQ/OQ/PQ execution
- Issue complete, auditready turnover packages to Operations and Quality
Regulatory & Quality Compliance
- Ensure alignment with site change control and regulatory impact assessment requirements
- Support regulatory filings, inspections, and audits as required
- Maintain project documentation in a state of inspection readiness
Closeout & Operations Readiness
- Deliver complete project closeout, including financial, technical, and regulatory documentation
- Support training, SOP updates, asset capitalization, and maintenance handover
- Capture and communicate lessons learned to improve future project delivery
Project Initiation & Planning
- Approved Project Charter and Capital Authorization
- Stakeholder & Communication Plan
- GMP Impact Assessment and Change Control initiation
- Initial Cost Estimate and Level 1-2 Schedule
Design & PreConstruction
- User Requirements Specification (URS)
- Basis of Design (BOD)
- GMP Design Review Packages
- Class 3/2 Cost Estimates
- Integrated Master Schedule
- Procurement and longlead strategy
Construction & Execution
- Construction Execution Plan and Site Logistics Plan
- Contractor contracts and bid evaluation documentation
- Weekly and monthly cost/schedule reports
- Change orders and field change documentation
- GMP construction compliance records
Commissioning, Qualification & Validation
- System Turnover Packages
- Commissioning Plans and Reports
- IQ/OQ/PQ support documentation
- Traceability between URS and qualification
Turnover & Closeout
- AsBuilt Drawings
- Asset Handover and Operations Readiness Package
- Final Cost Report and Forecast Variance Analysis
- Lessons Learned Report
- InService Date (ISD) approval documentation
Requirements:
- Bachelor's degree in Engineering, Construction Management, or related field
- Significant experience delivering capital projects in GMP manufacturing environments
- Strong construction execution and contractor management background
- Demonstrated knowledge of:
- GMP facility design and construction practices
- Commissioning and qualification processes
- Capital cost control, forecasting, and scheduling
- Proven ability to lead crossfunctional teams in regulated environments
Key Competencies:
- Capital project delivery leadership
- GMP and regulatory awareness
- Construction execution and problem solving
- Cost, schedule, and risk management
- Clear executivelevel communication