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 (KPIs):

• 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 performance (RIR, near-miss closure, LOTO compliance)
• Budget adherence (OPEX/CAPEX), spare parts inventory accuracy/turns
• Capital project delivery (scope, schedule, cost, qualification/closeout)

Education:

• Bachelor's degree in Engineering, Science, or a closely related technical field (Mechanical, Electrical, Chemical, Industrial, or similar)
• Advanced degree (MS/MBA) or Professional Engineer (PE) preferred

Required Experience and Skills:

• 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.

Technical Skills:

• 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.

Compliance and Safety:

• Demonstrated knowledge of cGMP, EHS, and relevant Safety, Environmental, Industrial Hygiene, and Labor regulations.
• Experience leading audits/inspections, deviations, investigations, and CAPA.

Leadership and Business:

• 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 Experience and Skills:

• 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.

Competencies:

• Strategic thinking and execution
• Technical depth in maintenance, utilities, and engineering
• Financial acumen and cost control
• Compliance and risk management
• Continuous improvement and problem solving
• Coaching, talent development, and inclusive leadership
• Stakeholder influence and cross-functional collaboration

Required Skills:
Accountability, Contractor Oversight, Cross-Cultural Awareness, Customer-Focused, Customer Service Leadership, Engineering Design, Ethical Compliance, Facility Management, Innovation, Leadership, Management Process, Operations Management, People Leadership, Professional Engineering, Risk Management, Team Leadership, Utilities Management, Visionary Thinking

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.--As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.- For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

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We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.

Learn more about your rights, including under California, Colorado and other US State Acts

U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote".

The salary range for this role is
$231,900.00 - $365,000.00

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits.- Available benefits include 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. More information about benefits is available at .

You can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

San Francisco Residents Only: -We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only: -We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance

Search Firm Representatives Please Read Carefully-
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. -No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.-

Employee Status:
Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:
Not Applicable

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:
01/24/2026
*A job posting is effective until 11:59:59PM on the day BEFORE -the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID: R381207