Merck
SME Associate Director, Electrical & Utilities Engineer
The SME Associate Director, Electrical & Utilities 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. Individual contributor role working with Staff and Technician 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, engineering design guidelines and business plan; receives guidance from manager when necessary. Provides & implements technical guidance to given tasks, 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 Utility equipment related projects, scope including but not limited to acquiring funding, change control, installation & integration, commissioning, and equipment qualification. Obtains bids, reviews contracts, supervises, and follows-up on contract work including. Actively participates in, contributes to, and completes items within shutdown schedule including all maintenance, calibration, assigned capital project work, and support Good Manufacturing Practice (GMP) operations for all facility shutdowns Coordinates with Site Engineering and Integrated Process Team (IPT) production planners Attends daily shutdown meetings ensuring owned activities are tracked and completed Develops detailed understanding of design, construction, control and maintenance of building 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. 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 are needed. Engineer must be have in depth experience (without further skills training) working with industrial electrical distribution (low/medium voltages), HVAC/R systems, utility generation equipment, PLC's, VFD's, and automation (BAS) systems in a Good Manufacturing Practices (GMP)environment. Must be 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. 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 Electrical and Automation 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 The successful candidate must have strong problem-solving skills and a hands-on approach to problem solving. The successful candidate should be able to examine an issue from diverse perspectives (safety, compliance, automation, equipment, process, and people) in order to best understand and identify root cause and then fix then fix implement corrective and preventative actions to prevent repeat failures. 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. Explains difficult concepts and persuades others to adopt point of view. Communicates information, asks questions and checks for understanding. Provide clarification in person and in writing for streamlined communication. Accountable for the their own performance and performance of plant engineering systems and maintenance. Makes decisions
guided by policies, guidelines, design practices, and procedures
that impact the department's ability to meet performance objectives Consults on an as-needed basis with next-level manager on more complex decisions and/or issues that impact other units with inter-related processes Adapts and implements departmental plans and priorities based on division scorecard to address local business, service and operational challenges Consults on an as-needed basis with next-level manager for newly identified priorities. Lead initiatives and see through to completion. 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 Forecasts resource needs; manages allocated expense budgets Forecasts resource needs; manages allocated resources to implement projects Reports to Plant Engineering Manager Frequent interaction with employees from other departments Interacts with representatives from regulatory agencies Collaborates with the production area maintenance technicians and engineers to maintain utility up-time for all production equipment. 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. Establish processes that ensure required Safety guidelines are followed and participates in divisional Safety Audit activities Assists in deviation investigations for maintenance instruments, equipment, and systems. Education Minimum Requirement: Bachelor's Degree in Engineering, Science or related field Required Experience and Skills: Eight years of experience with an Engineering or production and/or calibration and/or maintenance background Strong planning, scheduling, and time management skills Knowledge of regulatory requirements in accordance with Good Manufacturing Practice manufacturing operations Good oral and written communication skills Familiarity with Good Manufacturing Practice compliant calibration and maintenance databases Experience with formal problem-solving techniques, such as root cause analysis (RCA), failure mode effects analysis (FMEA, and/or Lean Six Sigma tools. Knowledge of "World Class" maintenance practices is paramount (e.g. PMs, RCM, PdM, etc.) and their implementation. Fully proficient in
The SME Associate Director, Electrical & Utilities 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. Individual contributor role working with Staff and Technician 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, engineering design guidelines and business plan; receives guidance from manager when necessary. Provides & implements technical guidance to given tasks, 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 Utility equipment related projects, scope including but not limited to acquiring funding, change control, installation & integration, commissioning, and equipment qualification. Obtains bids, reviews contracts, supervises, and follows-up on contract work including. Actively participates in, contributes to, and completes items within shutdown schedule including all maintenance, calibration, assigned capital project work, and support Good Manufacturing Practice (GMP) operations for all facility shutdowns Coordinates with Site Engineering and Integrated Process Team (IPT) production planners Attends daily shutdown meetings ensuring owned activities are tracked and completed Develops detailed understanding of design, construction, control and maintenance of building 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. 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 are needed. Engineer must be have in depth experience (without further skills training) working with industrial electrical distribution (low/medium voltages), HVAC/R systems, utility generation equipment, PLC's, VFD's, and automation (BAS) systems in a Good Manufacturing Practices (GMP)environment. Must be 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. 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 Electrical and Automation 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 The successful candidate must have strong problem-solving skills and a hands-on approach to problem solving. The successful candidate should be able to examine an issue from diverse perspectives (safety, compliance, automation, equipment, process, and people) in order to best understand and identify root cause and then fix then fix implement corrective and preventative actions to prevent repeat failures. 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. Explains difficult concepts and persuades others to adopt point of view. Communicates information, asks questions and checks for understanding. Provide clarification in person and in writing for streamlined communication. Accountable for the their own performance and performance of plant engineering systems and maintenance. Makes decisions
guided by policies, guidelines, design practices, and procedures
that impact the department's ability to meet performance objectives Consults on an as-needed basis with next-level manager on more complex decisions and/or issues that impact other units with inter-related processes Adapts and implements departmental plans and priorities based on division scorecard to address local business, service and operational challenges Consults on an as-needed basis with next-level manager for newly identified priorities. Lead initiatives and see through to completion. 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 Forecasts resource needs; manages allocated expense budgets Forecasts resource needs; manages allocated resources to implement projects Reports to Plant Engineering Manager Frequent interaction with employees from other departments Interacts with representatives from regulatory agencies Collaborates with the production area maintenance technicians and engineers to maintain utility up-time for all production equipment. 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. Establish processes that ensure required Safety guidelines are followed and participates in divisional Safety Audit activities Assists in deviation investigations for maintenance instruments, equipment, and systems. Education Minimum Requirement: Bachelor's Degree in Engineering, Science or related field Required Experience and Skills: Eight years of experience with an Engineering or production and/or calibration and/or maintenance background Strong planning, scheduling, and time management skills Knowledge of regulatory requirements in accordance with Good Manufacturing Practice manufacturing operations Good oral and written communication skills Familiarity with Good Manufacturing Practice compliant calibration and maintenance databases Experience with formal problem-solving techniques, such as root cause analysis (RCA), failure mode effects analysis (FMEA, and/or Lean Six Sigma tools. Knowledge of "World Class" maintenance practices is paramount (e.g. PMs, RCM, PdM, etc.) and their implementation. Fully proficient in