Executive Director, Engineering

Merck•Durham, NC

3d•Hybrid

About The Position

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.

Requirements

Bachelor’s degree in Engineering, Science, or a closely related technical field (Mechanical, Electrical, Chemical, Industrial, or similar)
15+ years total in industrial plant engineering, maintenance, and/or utilities management within GMP or highly regulated manufacturing environments, covering production equipment, clean utilities, building services, and facilities/utilities project engineering.
5+ years leading people, including through managers and individual contributors, in multi-disciplinary maintenance/engineering organizations.
Track record owning maintenance and calibration programs, reliability improvement initiatives, and capital project delivery (scope, cost, schedule, quality, qualification/validation).
Proficiency with CMMS/EAM and GMP-compliant calibration systems; experience analyzing maintenance data to reduce reactive work and increase reliability.
Working knowledge of SAP (Plant Maintenance and spare parts procurement) or equivalent ERP.
Strong understanding of utilities operations (boilers, refrigeration, HVAC, electrical distribution, compressed air, water systems, wastewater/storm water) and associated regulatory requirements.
Familiarity with automation/controls environments and collaboration with OEMs/vendors.
Demonstrated knowledge of cGMP, EHS, and relevant Safety, Environmental, Industrial Hygiene, and Labor regulations.
Experience leading audits/inspections, deviations, investigations, and CAPA.
Strong planning, scheduling, budgeting, and financial acumen for OPEX/CAPEX management.
Excellent analytical, decision-making, and problem-solving skills; effective written and oral communication.
Proven ability to drive continuous improvement and foster an inclusive, positive team culture.
Background in reliability engineering, RBAM/RCM/FMEA, and root cause analysis.
Experience with shutdown/turnaround management and multi-site coordination.

Nice To Haves

Advanced degree (MS/MBA) or Professional Engineer (PE) preferred
Certifications: PMP, CMRP/CRE, Six Sigma/Lean.
Experience with shutdown/turnaround management and multi-site/COE collaboration.
Direct experience in pharmaceutical or biopharmaceutical manufacturing, including equipment qualification/validation and change control.
Familiarity with automation/controls and vendor/OEM management.

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.

Benefits

medical, dental, vision healthcare and other insurance benefits (for employee and family)
retirement benefits, including 401(k)
paid holidays, vacation, and compassionate and sick days

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