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NCBiotech

Senior Specialist, Engineering

NCBiotech, Durham, North Carolina, United States, 27703

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Job Description The Utility Engineer is a member of the Plant Engineering team providing direct hands‑on technical support to the Durham Site. The site includes an Energy Center, Vaccines DP and DS Manufacturing Facilities, Quality Labs, various other manufacturing buildings and Maintenance and Material Storage Facility (MMSF). This support position will focus on leading investigation of electrical system excursions, engineering maintenance, design system improvements and optimizations, and hands‑on troubleshooting. This individual will provide input to the deviation investigation process for determination of root cause, recommend corrective actions to prevent re‑occurrence and help assess the impact on operations. The incumbent will also be responsible for leading plant engineering’s improvement projects and implementation of productivity enhancement initiatives.

General Summary The Utility Engineer will provide leadership in troubleshooting and improving plant utility systems, ensuring compliance with cGMP and supporting production schedules across multiple facilities.

General Profile

Individual contributor role working with professional employees and/or contractors.

Contributes to the performance and results of the department.

Adapts departmental plans and priorities to address resource and operational challenges.

Decisions are guided by policies, procedures and business plan; receives guidance from manager.

Provides technical guidance to employees, colleagues or contractors.

Anticipates and interprets client and/or customer needs to identify solutions.

Works as a liaison between Plant Engineering and other Site Business Partners.

Team member for small capital projects for plant engineering.

Ensures utility operations daily priorities and schedules project/work meeting the criteria established by site objectives.

Support / lead major utility equipment related projects, scope including funding, change control, integration, commissioning, and equipment qualification.

Obtains bids, reviews contracts, supervises, and follows‑up on contract work.

Actively participates in and contributes to shutdown schedule including all maintenance, calibration, capital project work, and GMP cleaning for all facility shutdowns.

Coordinates with Site Engineering and IPT production planners.

Attends daily shutdown meetings ensuring owned activities are tracked and completed.

Systems and process equipment. Provides technical support and training to mechanics and other maintenance personnel.

Interface with safety, production, and quality groups to ensure facility operations and systems comply with required standards.

Lead/participate in discussions with contractors, vendors, or other third‑party organizations to ensure consistency with overall maintenance and reliability objectives.

Participate in cross‑functional teams for engineering operations projects, or other plant activities as needed.

Works to streamline and improve maintenance department systems, procedures and ways of working with a focus on safety, current cGMP compliance and efficiency.

Define requirements and specifications for equipment.

Manage the implementation of new equipment and/or modifications to existing equipment.

Be the lead with regards to installation, upgrades, and dependability issues, and lead or assist in troubleshooting processes or equipment issues.

Ability to work independently, set priorities, and drive results at the same time able to work on a production team driving team goals.

Work hands‑on to troubleshoot and understand electrical system and equipment issues around the site.

Assists in deviation investigations for maintenance instruments, equipment, and systems.

Business Expertise

Applies skills to align work activities with department objectives.

Project management: manages project priorities – schedule & cost, installation.

Extensive industrial experience involving utility system generation, distribution and controls; in‑depth experience working with industrial utility generation equipment – boilers, chillers, compressors, pumping distribution systems, etc.

Fully aware of requirement specifications from a qualification perspective (IC/OC, IQ/OQ, CRs, etc.).

Actively search for ideas and ways to reduce expenses and improve quality without compromising superior customer service.

Functional Expertise

Lead identification and implementation of process improvement projects, productivity initiatives and corrective actions while focusing on equipment up‑time, minimizing cost and maintaining process consistency.

Provide input to investigate deviations with responsibility to interface with Operations, Global Vaccine Technology (GVTE), Automation, and Quality approvers.

Review design & engineering records and related GxP documentation, identifying and resolving discrepancies in a timely manner, and implementing corrective actions to improve the audit process for equipment.

Develop training material; as SME provide necessary training for system maintenance.

Work alongside operations and lean six sigma teams to develop reliable, consistent manufacturing processes that meet current GxP requirements.

Knowledgeable of all utility systems regarding functionality of equipment and relied on as SME during regulatory discussions for utilities and commissioning of equipment.

Problem Solving

Identifies and resolves technical and operational problems; collaborates with peers to resolve problems that cross inter‑related units.

Strong problem‑solving skills and a hands‑on approach; examines issues from diverse perspectives (safety, compliance, automation, equipment, process, people) to identify root cause and implement corrective and preventative actions.

Responsible for identification, development, and implementation of new systems that enhance plant engineering processes.

Assist troubleshooting plant engineering equipment as needed – chillers, boilers, AHUs, PLCs, humidifiers/dehumidifiers, water systems, Square D controllers/monitors, clean steam generators, refrigeration systems, cryogenic storage.

Perform engineering tasks to maintain plant utilities equipment.

Impact

Influence.

Explains difficult concepts and persuades others to adopt a point of view.

Communicates information, asks questions, and checks for understanding. Provides clarification in person and in writing for streamlined communication.

Accountability

Accountable for own performance and performance of plant engineering systems and maintenance.

Decision Making

Guided by policies, guidelines, design practices, and procedures; consults with manager on complex decisions impacting other units.

Strategic Planning

Adapts and implements departmental plans and priorities based on division scorecard to address local business, service and operational challenges.

Consults with manager for newly identified priorities.

Leads initiatives and sees them through to completion.

Identifies and implements preventative and predictive maintenance programs to assure compliance with quality, regulatory, and reliability requirements.

Tracks maintenance and reliability metrics and KPIs; benchmarks against industry data; continuous improvement opportunities.

Resource Management

Forecasts resource needs; manages expense budgets for tasks.

Manages resources to implement projects.

Maintains strong working relationships.

Reports to Plant Engineering Manager.

Frequent interaction with employees from other departments.

Interacts with regulatory agencies.

Collaborates with production maintenance technicians and engineers to maintain utility uptime for all production equipment.

Identifies revisions, deletions, or additions to calibration and maintenance programs to ensure compliance with safety, GxP and procedures.

Establishes processes to ensure safety guidelines and participates in safety audits.

Assists in deviation investigations for maintenance instruments, equipment, and systems.

Position Qualifications Education Minimum Requirement:

Bachelor’s degree in engineering, science or related field.

Five years of experience in production, calibration and/or maintenance.

Strong planning, scheduling and time management skills.

Knowledge of regulatory requirements in accordance with 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 such as RCA, FMEA, Lean Six Sigma.

Familiarity with “World Class” maintenance practices (PMs, RCM, PdM, etc.).

Fully proficient in understanding the functionality of all utility generation equipment (electric distribution, clean utilities, boilers, chillers, clean steam, HVAC/R and others).

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.

Preferred Experience and Skills:

CMMS experience related to plant maintenance and spare parts procurement systems.

Project management, including change control and equipment qualification.

SAP experience related to plant maintenance and spare parts procurement systems.

Familiarity with current GxP experience in a sterile, bulk or finished pharmaceutical environment.

Experience in automation and manufacturing execution systems (MES), process modeling and improvement.

Mechanical functionality and reliability knowledge (asset management).

Green Belt/Black Belt Certification.

Professional Engineer credentials.

Required Skills: 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 Projects, Productivity Improvements, Project Management, Regulatory Audits, Sterile Manufacturing, System Maintenance, Team Leadership, Troubleshooting, Utility Plant Operations.

Preferred Skills: [primarily internal references – retained for reference]

Current Employees apply HERE.

Current Contingent Workers apply HERE.

US and Puerto Rico Residents Only:

Our company is committed to inclusion. Please click here if you need an accommodation during the application or hiring process.

U.S. Hybrid Work Model Effective September 5, 2023, employees in office‑based positions in the U.S. will work a hybrid model: three total days on‑site per week, Monday‑Thursday, with Friday remote unless business‑critical tasks require on‑site presence. This model does not apply to field‑based, facility‑based, manufacturing‑based, or research‑based positions. Positions covered by collective‑bargaining agreements, remote roles, or those requiring onsite attendance are exempt.

The salary range for this role is $114,700.00 - $180,500.00.

We offer a comprehensive package of benefits including medical, dental, vision, retirement, paid holidays, vacation and other benefits. More information available at https://jobs.merck.com/us/en/compensation-and-benefits.

You can apply for this role through https://jobs.merck.com/us/en. The application deadline is stated on this posting.

San Francisco Residents Only:

We will consider qualified applicants with arrest and conviction records 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, consistent with local laws.

Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, does not accept unsolicited assistance from search firms. CVs/resumes submitted by search firms without a valid written agreement will be deemed the sole property of the company. No fee will be paid if a candidate is hired without an existing agreement. Agency introductions are position specific.

Employee Status:

Regular

Relocation:

Domestic

Visa Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Not Applicable

Shift:

1st – Day

Valid Driving License:

No

Hazardous Materials:

N/A

Job Posting End Date:

01/9/2026

Requisition ID:

R378155

*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.

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