Director of Capital Projects

Role Summary

Director of Capital Projects at Organogenesis overseeing the comprehensive lifecycle of all construction initiatives, including strategic planning, design, engineering, and construction of capital projects that support manufacturing and logistics objectives. Includes new facilities, upgrades to clean rooms, shipping areas, offices, laboratories, and commissioning/startup activities with QSR documentation and project timeline management.

Responsibilities

• Manage project lifecycles effectively, utilizing robust cost controls and resource allocation to meet deadlines and budgets
• Report project progress and outcomes to stakeholders
• Develop and manage Facilities capital budget for Organogenesis
• Develop processes and SOPs to support large-scale capital projects
• Develop procedures and systems to ensure projects meet governmental regulations and QSR requirements
• Ensure GMP documentation needs are met (URS, FRS, and submittals to support commissioning and validation)
• Ensure PCO and ECR processes are followed for approved facility modifications, including commissioning and validation support
• Ensure new projects meet corporate growth goals
• Manage contracts and construction plans for all new facilities
• Manage project construction personnel, project engineers, and contractors
• Additional related duties as assigned

Qualifications

• BS in an engineering discipline (mechanical, chemical, industrial technology or equivalent) required
• MS in relevant field preferred
• 12+ years of experience managing Capital Projects in Biotechnology, Medical Device or Pharmaceutical space
• Experience managing full project lifecycle required
• Deep understanding of mechanical utility systems (HVAC, steam, high purity systems, compressed air, vacuum) required
• Knowledge of automated monitoring and control systems required
• Experience managing significant financial resources and developing budgets required
• Strong commitment to customers and quality in a QSR environment
• Ability to manage multiple projects and priorities while maintaining GMP documentation
• Strong understanding of local, state, and federal code and permitting requirements
• Ability to read and interpret safety rules, operating and maintenance instructions, and procedure manuals
• Excellent leadership, written and verbal communication, problem-solving, and decision-making skills
• Proven analytical skills to define problems, collect data, establish facts, and draw conclusions while interpreting technical instructions

Skills

• Project management and lifecycle oversight
• Budget development and financial management
• Regulatory compliance and QSR/GMP documentation
• Facilities planning and construction management
• Leadership and cross-functional collaboration
• Analytical problem solving and data interpretation

Education

• BS in engineering required; MS preferred

Additional Requirements

• Physical demands: includes climbing stairs/ladders, working in confined spaces, gowning for clean rooms, exposure to high noise levels, and construction site work; reasonable accommodations available
• Working hours may include non-regular business hours (weekends and weeknights)