Description

The Associate Director of Capital Projects is responsible for the strategic planning, execution, and oversight of capital projects at the CDMO site. This role provides leadership for project management, engineering design, procurement, construction, and validation of facilities, utilities, and manufacturing equipment. The position ensures that all projects meet regulatory compliance requirements (cGMP, FDA, OSHA), are delivered on time and within budget, and align with business goals and operational excellence initiatives.

• Lead the planning and execution of site capital projects from concept through handover, ensuring quality, safety, cost, and schedule objectives are met.
• Develop and manage multi-million-dollar capital budgets and resource plans in collaboration with site leadership and global engineering teams.
• Oversee cross-functional teams including engineering, validation, quality, procurement, and operations personnel to ensure project alignment with site needs.
• Act as the primary liaison with external architects, engineers, contractors, and regulatory authorities for capital initiatives.
• Ensure all projects comply with GMP, environmental, health and safety (EHS), and regulatory requirements.
• Provide technical leadership in facility design, utility systems (HVAC, WFI, clean steam), and process equipment implementation.
• Drive risk management strategies, contingency planning, and change control processes throughout project lifecycles.
• Prepare and present project updates, metrics, and risk assessments to senior management and stakeholders.
• Mentor and develop junior and experienced project engineers to support a high-performance project team.

All employees are required to adhere to OSHA, DEA, EPA, FDA and cGMP regulations as they relate to the operation of the Company; and to adhere to all company safety rules and procedures.  All employees are expected to report to work regularly and promptly.  Other duties relating to departmental mission, not specifically detailed in this section may be assigned.

• Bachelor's degree in Engineering, Construction Management, or a related field required; Master's degree preferred.
• Minimum of 10 years of experience in capital project execution within the pharmaceutical, biotech, or CDMO industry.
• At least 5 years in a leadership or managerial capacity overseeing cross-functional project teams.
• Demonstrated experience managing complex capital projects ($10M+) in a regulated manufacturing environment.

PI277795131