MSD-posted 1 day ago
Full-time • Mid Level
Hybrid • Durham, NC
5,001-10,000 employees

GENERAL SUMMARY : 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 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 Partner’s 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 including. 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 as necessary 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 Good Manufacturing Practices (cGMP) compliance and efficiency. Define requirements and specifications for equipment. Manage the implementation of new equipment and/or the modifications to existing equipment Be the lead with regards to installation, upgrades, and dependability issues, and lead or assist in trouble shooting 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

  • 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 including.
  • 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 as necessary 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 Good Manufacturing Practices (cGMP) compliance and efficiency.
  • Define requirements and specifications for equipment.
  • Manage the implementation of new equipment and/or the modifications to existing equipment
  • Be the lead with regards to installation, upgrades, and dependability issues, and lead or assist in trouble shooting 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
  • Lead in the 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 (both minor and major), with responsibility to interface with Operations, Global Vaccine Technology (GVTE), Automation, and Quality approvers.
  • Perform a thorough review of design & engineering records and related Good Manufacturing Practices documentation, identifying and resolving discrepancies in a timely manner, and implementing corrective actions to improve the execution/review process for equipment.
  • Develop training material.
  • Working as a subject matter expert (SME), provide necessary training for system maintenance.
  • Work alongside operations and lean six sigma team members to develop reliable, consistent manufacturing processes that meet current Good Manufacturing Practices requirements.
  • Knowledgeable of all utility systems regarding functionally of equipment and relied on as SME during regulatory discussions for Utilities and the commissioning of that equipment.
  • Identifies and resolves technical and operational problems; collaborates with peers to resolve problems that cross into inter-related units
  • Responsible for the identification, development, and implementation of new systems which enhances the operation of Plant Engineering processes.
  • Assist with trouble shooting Plant Engineering equipment on an as needed basis which includes but limited to chillers, boiler, AHUs, PLCs, humidifiers/dehumidifies, water systems, Square D controllers/monitors, clean steam generators, refrigeration systems, and cryogenic storage.
  • Perform engineering task as needed to maintain plant utilities equipment.
  • Responsible for the identification and implementation of preventative and predictive maintenance programs to assure compliance with quality, regulatory, and reliability requirements and goals.
  • Track maintenance and reliability metrics and key performance indicators.
  • Benchmark performance indicators against industry data.
  • Look for continuous improvements opportunities
  • Identifies revisions, deletions, or additions to the calibration and maintenance programs to ensure that calibration and maintenance activities are completed in accordance with established safety, Good Manufacturing Practices (GMP), and calibration/maintenance procedures.
  • Assists in deviation investigations for maintenance instruments, equipment, and systems.
  • Bachelor’s degree in engineering, Science or related field
  • Five years of experience in a production and/or calibration and/or maintenance background
  • Strong planning, scheduling, and time management skills
  • Working knowledge 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 root cause analysis (RCA), failure mode effects analysis (FMEA, and/or Lean Six Sigma tools.
  • Familiarity of “World Class” maintenance practices is paramount (e.g. PMs, RCM, PdM, etc.)
  • Fully proficient in understanding the functionality of all utility generation equipment (e.g. electrical distribution, clean utilities, Boilers, Chillers, wfi/clean steam, HVAC/R, and utility generation equipment.
  • 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
  • SAP experience related to plant maintenance and spare parts procurement systems
  • Familiarity with current Good Manufacturing Practices experience in a sterile, bulk or finished pharmaceutical environment
  • Experience in automation and manufacturing execution systems (MES), process modeling and process improvement.
  • Mechanical functionality and reliability knowledge (asset management)
  • Green Belt/Black Belt Certification
  • Professional Engineer
  • 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 https://jobs.merck.com/us/en/compensation-and-benefits
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