Merck · 17 hours ago
Executive Director, Engineering
Merck is a leading pharmaceutical company seeking an Executive Director of Engineering to lead their Maintenance and Engineering functions at the Durham site. This role involves providing strategic direction, ensuring compliance, and driving continuous improvement across various production areas and utilities.
BiotechnologyHealth CareMedicalPharmaceutical
Responsibilities
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 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
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
Qualification
Required
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
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
Benefits
Medical
Dental
Vision healthcare and other insurance benefits (for employee and family)
Retirement benefits, including 401(k)
Paid holidays
Vacation
Compassionate and sick days
Company
Merck
Merck is a biopharmaceutical company that offers medicines and vaccines for various diseases.
Funding
Current Stage
Public CompanyTotal Funding
$5.59MKey Investors
Private Capital AdvisorsGavi, the Vaccine Alliance
2018-11-25Post Ipo Equity· $0.59M
2016-01-21Series Unknown· $5M
1980-12-19IPO
Leadership Team
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