The Capital Project Manager is responsible for the end‑to‑end 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 cross‑functional 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 phase‑gate 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 forecast‑at‑completion 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, audit‑ready 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 & Pre‑Construction

• User Requirements Specification (URS)
• Basis of Design (BOD)
• GMP Design Review Packages
• Class 3/2 Cost Estimates
• Integrated Master Schedule
• Procurement and long‑lead 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

• As‑Built Drawings
• Asset Handover and Operations Readiness Package
• Final Cost Report and Forecast Variance Analysis
• Lessons Learned Report
• In‑Service 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 cross‑functional 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 executive‑level communication