Senior Specialist, Engineering

Senior Specialist, Engineering (Merck)

Durham, NC

Salary range: $ - $

Hybrid work model: 3 on‑site days per week (Monday – Thursday) and 1 remote day (Friday) unless business‑critical tasks require presence.

The Utility Engineer is a member of the Plant Engineering team providing direct hands‑on technical support to the Durham Site, which includes an Energy Center, Vaccines DP and DS Manufacturing Facilities, Quality Labs, various other manufacturing buildings and Maintenance and Material Storage Facility (MMSF). This role focuses on leading investigation of electrical system excursions, engineering maintenance, design system improvements, optimization, hands‑on troubleshooting, deviation investigation, root‑cause determination, corrective action recommendation, and plant engineering improvement projects.

• Lead investigation of electrical system excursions and root‑cause analysis.
• Provide technical guidance and troubleshoot electrical equipment, including boilers, chillers, compressors, pumps, AHUs, PLCs, heaters, humidifiers, and cryogenic storage.
• Support and lead major utility equipment related projects—scope, funding, change control, integration, commissioning, equipment qualification.
• Coordinate and oversee shutdown schedules, including maintenance, calibration, capital project work, and GMP cleaning.
• Interface with safety, production, quality and regulatory groups to ensure operations meet required standards.
• Define requirements and specifications for equipment and manage implementation of new or modified equipment.
• Provide input to deviation investigations for maintenance instruments, equipment, and systems.
• Identify and execute process improvement projects, productivity initiatives, and corrective actions to improve uptime and reduce costs.
• Develop training materials and train maintenance personnel.
• Build and maintain preventive and predictive maintenance programs.
• Track maintenance and reliability metrics and KPIs, benchmark against industry data.
• Participate in cross‑functional teams for engineering operations projects and plant activities.
• Support plant engineering’s improvement projects and implement productivity enhancement initiatives.

Education Minimum Requirement: Bachelor’s degree in engineering, science or related field.

• Five years of experience in production, calibration, and/or maintenance background.
• Strong planning, scheduling, and time‑management skills.
• Working knowledge of regulatory requirements in GMP manufacturing operations.
• Good oral and written communication skills.
• Experience with GMP compliant calibration and maintenance databases.
• SAP experience related to plant maintenance and spare parts procurement systems.
• Experience with formal problem‑solving techniques (RCA, FMEA, Lean Six Sigma tools).
• Familiarity with “World Class” maintenance practices (PMs, RCM, PdM, etc.).
• Fully proficient understanding of utility generation equipment (electrical distribution, clean utilities, boilers, chillers, wfi/clean steam, HVAC/R).
• Utility and HVAC system process improvement and optimization experience.
• Technical writing and deviation investigation experience.
• Experience in problem solving and troubleshooting.
• Familiarity with cGMPs and vaccine regulatory requirements.

• CMMS experience related to plant maintenance and spare parts procurement systems.
• Project management, including change control and equipment qualification.
• Familiarity with current Good Manufacturing Practices in a sterile, bulk or finished pharmaceutical environment.
• Experience in automation and MES, process modeling and process improvement.
• Mechanical functionality and reliability knowledge (asset management).
• Green Belt/Black Belt Certification.
• Professional Engineer certification.

• Adaptability, Business Planning, Capital Project Management, cGMP Regulations, Change Management, Curriculum Development, Data Analysis, Deviation Investigations, Equipment Qualification, Facility Management, Good Manufacturing Practices (GMP), Implementation Management, Maintenance Supervision, Occupational Safety and Health, Process Improvement…