Executive Director, Engineering

Job Description

The Executive Director, Maintenance and Engineering leads the HPV, VMF, Flash and Teknika Production Areas Maintenance, Clean Utilities, Site‑wide Utilities, Site Services and Site Engineering functions for the Durham site.

As a member of the Durham Site Leadership Team, this role provides strategic and tactical direction to ensure asset reliability, cGMP/EHS compliance, effective shutdown and project execution, and efficient operations within budget. The leader drives continuous improvement, fosters an inclusive and positive culture, and partners with Operations/IPTs, GES, COEs, Automation, Reliability, Quality, EHS and Finance to achieve safety, quality, service and cost objectives.

• Set the vision and multi‑year strategy for maintenance, utilities and engineering aligned to business goals, capacity needs and compliance requirements.
• Serve on the Durham Site Leadership Team; influence site priorities and resource allocation.
• Build and develop a high‑performing organization (~200 employees) including associate directors, managers, engineers, technicians and coordinators; coach/mentor leaders and ICs.
• Promote an inclusive, positive culture emphasizing safety, quality, continuous improvement and accountability.
• Ensure all Maintenance, Utilities, Site Services and Engineering processes comply with cGMP;
  Safety;
  Environmental;
  Industrial Hygiene; ANSI and Labor regulations.
• Own audit readiness and respond to/resolve compliance gaps from audits and deviations; lead or support investigations and corrective/preventive actions (CAPA).
• Establish and enforce procedures for lockout/tagout, machine guarding, risk assessments, Electrical Safety, Hot Work, Line‑Breaking, Confined Space, Elevated Work, PSM elements as applicable and contractor management.
• Direct preventive, predictive and corrective maintenance programs for HPV, Flash, VMF and Teknika production equipment, clean utilities, facilities and site services.
• Ensure equipment calibration programs are GMP‑compliant; maintain the integrity of equipment identification and specifications within the computerized maintenance/calibration management system.
• Manage shop‑floor support to meet safety, compliance, production and financial goals; reduce reactive work by analyzing completed work orders and driving reliability actions.
• Oversee spare parts strategy including risk‑based assessments, obsolescence replacement, storeroom controls and SAP plant maintenance/spare‑parts procurement processes.
• Lead operation and maintenance of all plant utilities and distribution networks: boilers, refrigeration, HVAC, electrical substations, compressed air, potable/distilled water, dust collection, wastewater, storm water and related systems.
• Coordinate site services (building, building services, grounds, waste and facility support) to ensure reliable, compliant operation.
• Drive sustainability initiatives, ensuring regulatory compliance and implementing strategies for continuous improvement.
• Partner with reliability engineers to conduct RBAM, RCM/FMEA, root cause analysis and implement area‑specific reliability actions to improve uptime, MTBF/MTTR and OEE.
• Collaborate with Automation for troubleshooting and maintenance of automated equipment; engage vendors and OEMs to resolve complex issues and improve performance.
• Monitor performance of maintenance, calibration, equipment and utilities operations; identify improvement opportunities and drive continuous improvement initiatives.
• Own master shutdown schedules and execution across maintenance, calibration, capital project work and GMP cleaning; chair/attend daily shutdown meetings to track completion.
• Background in reliability engineering, RBAM/RCM/FMEA and root cause analysis.
• Experience with shutdown/turnaround management and multi‑site coordination.
• Familiarity with automation/controls and vendor/OEM management.
• Certifications:
  
  PMP, CMRP/CRE, Six Sigma/Lean, PE or equivalent.
• Key Performance Indicators:
  Asset availability/OEE; equipment reliability (MTBF/MTTR); planned vs. reactive work ratio; maintenance backlog; calibration compliance and audit outcomes; utilities uptime and energy efficiency; safety…