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Organogenesis · 14 hours ago

Director of Capital Projects

Smithfield, RI

Full-time

Onsite

Director/Executive

$185K/yr - $230K/yr

12+ years exp

Organogenesis is seeking a highly strategic and detailed-oriented person to join our team as the Director of Capital Projects. This role involves overseeing the comprehensive lifecycle of construction initiatives that support the organization's manufacturing and logistics objectives, including managing project timelines, budgets, and ensuring compliance with regulations.

BiotechnologyHealth CareManufacturingMedical

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 SOP’s 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. These documents include URS, FRS as well as submittals to support commissioning and validation processes

Ensure PCO and ECR processes are followed to make approved Facility modifications as needed to support manufacturing operations. This will include the commissioning phase as well as supporting 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

Qualification

Capital Project ManagementBudget DevelopmentMechanical Utility SystemsQSR ComplianceProject Lifecycle ManagementAutomated Control SystemsGMP DocumentationAnalytical SkillsLeadership SkillsCommunication SkillsProblem-Solving Skills

Required

BS in an engineering discipline such as mechanical, chemical, industrial technology or equivalent required

12 + years of experience managing Capital Projects in the Biotechnology, Medical Device or Pharmaceutical space

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

Position works heavily within the QSR environment and thus must have a high standard of commitment to customers and the quality of work

Must possess the ability to handle many projects and priorities at the same time and keep track of important GMP documentation

Strong understanding of local, state, and federal code and permitting requirements

Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals required

Excellent leadership, communication (both written and verbal), problem-solving, and decision-making skills

Proven analytical skills with the ability to define problems, collect data, establish facts, and draw valid conclusions, along with the aptitude to interpret a wide variety of technical instructions in mathematical or diagram form and manage multiple abstract and concrete variables