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.

Key Responsibilities:

Strategy and Leadership:

• 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.

Compliance, Quality, and EHS:

• 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.

Maintenance and Calibration Operations:

• Direct preventive, predictive, and corrective maintenance programs HPV, Flash, VMF and Teknika production equipment, clean utilities, facilities, and site services.

• Ensure equipment calibration programs are GMP-compliant; maintain 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.

Utilities and Site Services:

• 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.

Reliability and 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.

Shutdown and Turnaround Management:

• 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…