Manufacturing & Tech Ops - Senior Director

Key Responsibilities

• Serve as the system owner for assigned clean and black utility systems, including generation, distribution, instrumentation, and automation.
• Provide technical leadership and oversight for HVAC, clean utilities (WFI, clean steam), black utilities (chilled water, plant steam), CIP systems, autoclaves, parts washers, and high-purity gas systems.
• Lead conceptual, preliminary, and detailed engineering for new utility systems and modifications to existing equipment.
• Generate, review, and approve P&IDs, wiring diagrams, control panel layouts, and technical specifications.
• Oversee system startup, commissioning, qualification, troubleshooting, and optimization activities.
• Ensure utilities operate within defined regulatory, safety, and process limits.
• Partner with Validation and Quality teams to support investigations, deviations, and regulatory inspections.
• Manage vendor relationships during equipment fabrication, installation, repair, and service activities.
• Support capital project planning, including scope development, cost estimates, equipment procurement, and project approvals.
• Establish and manage preventive and routine maintenance strategies in collaboration with Maintenance.
• Lead and support change control activities, including automation and system changes.
• Drive continuous improvement initiatives and stay current with emerging technologies and cGMP expectations.

Experience Required

• Education: Bachelor’s Degree in Life Science, Engineering, or related discipline (OR a combination of equivalent work experience in capital project engineering, pharma cGMP facility start-up, CapEx/OpEx project management and/or comparable military experience).
• Years of Experience: 16-20 years of experience in utilities engineering, facilities engineering, or system ownership within a regulated manufacturing environment (biopharmaceutical, life sciences, or similar).
• Demonstrated experience supporting clean utility systems, HVAC, and regulated facility operations.
• Experience with commissioning, qualification, and cGMP compliance.
• Proven ability to work independently with minimal supervision while exercising sound technical judgment.
• Experience leading projects, vendors, or technical workstreams.