Director of Capital Projects

Role Summary

Organogenesis is seeking a highly strategic and detail-oriented leader to oversee the comprehensive lifecycle of all construction initiatives. The Director of Capital Projects manages the strategic planning, design, engineering, and construction of capital projects that support the organization’s manufacturing and logistics objectives, including new manufacturing and office buildings, logistics/warehousing facilities, and major upgrades to clean rooms, shipping areas, offices, and laboratories. The role implements commissioning and startup activities and maintains facilities-related QSR documentation, ensuring projects stay on track with timelines and achieve critical deadlines.

Responsibilities

• Manage project lifecycles effectively, utilizing robust cost controls and efficient resource allocation strategies to meet critical deadlines and budget requirements
• Responsible for reporting project progress and outcomes to stakeholders
• Develop and manage Facilities capital budget for Organogenesis
• Develop necessary processes and SOPs to support large-scale capital projects
• Develop procedures and systems to ensure projects meet governmental regulations and QSR requirements
• Ensure projects meet GMP documentation needs, including URS, FRS, and submittals to support commissioning and validation processes
• Ensure PCO and ECR processes are followed to make approved Facility modifications to support manufacturing operations, including commissioning and validation activities
• Ensure new projects meet expected corporate growth goals
• Manage the contracts and construction plans for all new facilities
• Responsible for managing project construction personnel, project engineers, and contractors
• Additional related duties as assigned

Qualifications

• Required: BS in an engineering discipline such as mechanical, chemical, industrial technology or equivalent
• Preferred: MS in a relevant field
• Required: 12+ years of experience managing Capital Projects in the Biotechnology, Medical Device or Pharmaceutical space
• Required: Experience managing full project lifecycle
• Required: Deep understanding of mechanical utility systems including HVAC, steam, high purity systems, compressed air, vacuum, etc.
• Required: Knowledge and understanding of automated monitoring and control systems
• Required: Experience managing significant financial resources and developing budgets
• Required: Works within a QSR environment with a high standard of commitment to customers and quality
• Required: Ability to handle many projects and priorities simultaneously and maintain GMP documentation
• Required: Strong understanding of local, state, and federal code and permitting requirements
• Required: Ability to read and interpret safety rules, operating and maintenance instructions, and procedure manuals
• Required: Excellent leadership, written and verbal communication, problem-solving, and decision-making skills
• Required: Proven analytical skills to define problems, collect data, establish facts, and draw valid conclusions, with ability to interpret diverse technical instructions

Skills

• Strategic thinking and project portfolio management
• Leadership and cross-functional collaboration
• Strong written and verbal communication
• Analytical and problem-solving abilities
• Regulatory compliance and quality system awareness

Education

• BS in engineering (required)
• MS in a relevant field (preferred)

Additional Requirements

• Physical Demands: Some physical exertion (climbing stairs/ladders, working in confined spaces); gowning for clean rooms; high noise levels in utility rooms; work on construction sites requiring balance and footing; exposure to hazardous chemicals; occasional work outside regular hours