Capital Project Manager

The Capital Project Manager will develop, implement, and oversee capital projects and equipment purchases to support biopharmaceutical Operations. This role is focused on managing projects ranging in size of up to $3 million. Duties include interfacing with cross-functionally with both internal teams and groups, and external suppliers to ensure projects are delivered on time and within budget. This position will utilize breadth of knowledge across facilities and engineering to ensure regulatory compliance and effective project execution.

REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities

  • Strong pharmaceutical project management skills and proven experience in having managed capital

    projects with emphasis on Biologics, clinical and/or manufacturing and development laboratories in a

    cGMP environment.

    • Project Management skills including the development and management of work breakdown structures, RACI diagrams, schedules, budgets, action trackers and meeting minutes.

    • Understanding of GMP, regulatory, environmental, and OSHA regulations as it relates to Engineering, Facilities Operations and Construction

    • Understanding of financial management as it relates to capital and expense spending and project cash flow forecasting. (i.e. Purchase Orders, Invoicing)

    • Experience in total project delivery in a cGMP environment (from concept to validation and startup process). Leads the development of the capital project scope and objectives in support of the business strategy dealing with clients and stakeholders.

    • Exhibits project leadership and effective decision making throughout each project. Leads and promotes effective teamwork by engaging both Facilities as well as including key clients and stakeholders.

    • Possesses broad knowledge of the functional requirements of pharmaceutical facilities and engineering best practices, while ensuring that appropriate internal and external resources are incorporated into the project design and execution.

    • Strong Understanding of GMP Facility Iso Standards, HVAC & Building Controls (Siemens). Knowledge of critical utility systems such as compressed air/gases, WFI, vacuum, waste, as well as security systems and policies.

    • Ability to read and understand architectural, MEP and P&ID Drawings

    • Proficient with construction terminology and legal content of construction contracts, documents and logistics.

    • Understanding of GMP Compliance related to Deviations, Investigations, CAPAs and Actions and document management systems

    • Familiar with the Stage Gate Process, SAP and Ariba (Purchase Order System) a plus.