Director of Engineering

About the role

My client is seeking a strategic and hands-on Director of Engineering to lead the facility expansion, maintenance, and process optimization initiatives of their pharmaceutical manufacturing plant. This is a critical leadership role where you will oversee the engineering lifecycle from the design and installation of new GMP equipment to the day-to-day reliability of utilities (WFI, clean steam, HVAC). You will mentor a team of 12 engineers and technicians, manage a $10M+ annual capital budget, and act as the primary technical interface with the FDA and client auditors regarding facility and equipment qualification.

Responsibilities

• Strategic Leadership: Develop and execute the 5-year engineering roadmap to support business growth, including the integration of Industry 4.0/IoT technologies into the manufacturing floor.
• Capital Project Management: Lead the $40M facility expansion project from conceptual design through commissioning, qualification, and validation (CQV) with strict adherence to FDA cGMP standards.
• Operational Excellence: Drive Continuous Improvement (Lean/Six Sigma) to reduce downtime, improve Overall Equipment Effectiveness (OEE), and reduce energy consumption across the plant.
• Compliance & Safety: Ensure all engineering systems (utilities, process piping, electrical) comply with OSHA, EPA, and FDA 21 CFR Part 11 regulations. Serve as the primary SME during regulatory inspections.
• Team Development: Recruit, train, and retain top engineering talent; foster a culture of accountability, safety, and innovation.

Requirements

• Bachelor’s Degree in Mechanical, Chemical, or Electrical Engineering required. M.S. or MBA preferred.
• Minimum of 10+ years in engineering management within FDA-regulated pharmaceutical, biotech, or medical device manufacturing. CDMO experience is a significant plus.
• Deep knowledge of GMP utilities (Purified Water, WFI, Clean Steam, Compressed Air), HVAC systems, and automated control systems.
• Exceptional project management skills (PMP preferred), strong financial acumen, and the ability to translate complex technical issues to non-technical executive stakeholders.