Associate Director, Plant Engineering
Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century. Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
Merck Manufacturing Division, MMD, is a team of dedicated, energetic individuals who are committed to being the most trusted supplier of pharmaceuticals and health products worldwide. Our facilities, along with our external contractors, suppliers, and partners, comprise an interdependent global manufacturing network that’s committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe.
The Associate Director Engineer is a member of the PlantEngineering team providing technical support to the Durham Site. The site includes an Energy Center, VaccinesManufacturing Facilities B101 and B102, Varicella Bulk Facility B130, QualityLabs, and Maintenance and Material Storage Facility (MMSF). This position willfocus on supporting and leading investigation of utility system excursions,system improvements and optimizations. This individual will provide input to the deviation investigationprocess for determination of root cause, recommend corrective actions toprevent reoccurrence and help assess the impact on operations. The incumbentwill also be responsible for leading plant engineering’s improvement projectsand implementation of productivity enhancement initiatives.
- Thismanagerial role involves working with professional employees and/orcontractors.
- Accountablefor contributes to the performance and results of the department.
- Adaptsdepartmental plans and priorities to address resource and operationalchallenges.
- Decisionsare guided by policies, procedures and business plan; Collaborates within thedepartment and other technical units when needed.
- Providestechnical guidance to employees, colleagues or contractors
- Anticipatesand interprets client and/or customer needs to identify solutions
- Works asa liaison between Plant Engineering and other Site Business Partner’s
- Teammember for small capital projects for plant engineering
- Ensuresutility operations daily priorities and schedules project/work meeting thecriteria established by site objectives.
- Support /lead major utility equipment related projects, scope including funding, changecontrol, integration, commissioning, andequipment qualification
- Whennecessary, obtains bids, reviews contracts, supervises, and follows-up on contractwork including.
- Participatesin and contributes to shutdown schedule including all maintenance, calibration,capital project work, and GMP Cleaning for all facility shutdowns
- Coordinateswith Focus Factory and IPT production planners
- Attendsdaily shutdown meetings as necessary ensuring department owned activities aretracked and completed
- Appliesskills to align work activities with department objectives
- Projectmanagement when necessary - (manages project priorities – schedule & cost,installation)
- Extensiveindustrial experience involving utility system generation, distribution andcontrols are needed. Associate Director of Engineer must be have in depthexperience working with industrial electrical distribution (low/mediumvoltages), HVAC/R systems, WFI, clean steam, utility generation equipment, andautomation (BAS) systems.
- Must befully aware of requirement specifications from a qualification perspective(IC/OC, IQ/OQ, CRs, etc.)
- Lead inthe identification and implementation of process improvement projects,productivity initiatives and corrective actions while focusing on equipmentuptime, minimizing cost and maintaining process consistency along with otherrelevant Reliability Metrics for the department.
- Provideinput to investigate deviations (both minor and major), with responsibility tointerface with Operations, GVTE (Global Vaccine Technology), Automation, andQuality approvers.
- Presentand defend investigations during regulatory inspections, as required.
- Whennecessary perform a thorough review of engineering records and related GMPdocumentation, identifying and resolving discrepancies in a timely manner, andimplementing corrective actions to improve the execution/review process.
- Ensuretraining for department is well developed material. Working as a subject matterexpert (SME), provide necessary training for system maintenance.
- Workalongside operations and lean six sigma team members to develop reliable,consistent manufacturing processes that meet cGMP requirements.
- Knowledgeableof all utility systems regarding functionally of equipment and relied on as SMEduring regulatory discussions.
- Whennecessary, Identifies and resolves technical and operational problems;collaborates with peers to resolve problems that cross into inter-related units
- Thesuccessful candidate must have strong problem solving skills and a hands-onapproach to problem solving. The successful candidate should be able to examinean issue from diverse perspectives (safety, compliance, automation, equipment,process, and people) in order to best understand and identify root cause.
- Responsiblefor assisting in the identification, development, and implementation of newsystems which enhances the operation of Plant Engineering processes.
- Whennecessary, assist with trouble shooting Plant Engineering equipment on an asneeded basis which includes but limited to chillers, boiler, AHUs, PLCs,humidifiers/dehumidifies, water systems, Square D controllers/monitors, cleansteam generators.
- Performengineering task as needed to maintain plant utilities equipment.
- Explainsdifficult concepts and persuades others to adopt point of view.
- Communicatesinformation, asks questions and checks for understanding
- Accountablefor the performance of plant engineering systems and maintenance concepts
- Makesdecisions – guided by policies, guidelines, and procedures – that impact thedepartment’s ability to meet performance objectives
- Consultson an as-needed basis with next-level manager on more complex decisions and/orissues that impact other units with inter-related processes
- Adaptsand implements departmental plans and priorities based on division scorecard toaddress local business, service and operational challenges
- Consultson an as-needed basis with next-level manager for newly identified priorities
- Developsoperating strategy from a utility perspective supporting site reliabilityinitiatives.
- Responsiblefor the maintenance cost center witin the Plant Engineering department, includingcreating and managing all profit plans a forecasts throughout the year.
- Forecastsresource needs; manages allocated expense budgets
- Forecastsresource needs; manages allocated resources to implement projects
- LeadsMaintenance and Engineering team for the department to support Focus Factory activitiesincluding co aches, technicians, and engineers (40-50 people)
- Serves asa leadership team member for the department.
- Coaches/mentorsreports responsible for each area within the department.
- Reportsto Maintenance, Reliability, Operations Engineering Director
- Frequentinteraction with employees from other departments
- Interactswith representatives from regulatory agencies
- Collaborateswith the production area maintenance technicians and engineers to maintainutility uptime for all production equipment.
- Identifiesrevisions, deletions, or additions to the calibration and maintenance programsto ensure that calibration and maintenance activities are completed inaccordance with established safety, GMP, and calibration/maintenanceprocedures.
- Helpsestablish processes that ensure required Safety guidelines are followed andparticipates in divisional Safety Audit activities
- Asneeded, assists in deviation investigations for maintenance instruments,equipment, and systems.
Education Minimum Requirement:
- Bachelor Degree in Engineering, Science or related field
Required Experience and Skills:
- 8 yearsof experience in a production and/or calibration and/or maintenance background
- Strongplanning, scheduling, and time management skills
- Peoplemanaging experience
- Workingknowledge regulatory requirements in accordance with GMP manufacturingoperations
- Good oraland written communication skills
- Experiencewith GMP compliant calibration and maintenance databases
- SAPexperience related to plant maintenance and spare parts procurement systems
- Experiencewith formal problem solving techniques, such as root cause analysis (RCA),failure mode effects analysis (FMEA, and/or Lean Six Sigma tools.
- Familiarityof “World Class” maintenance practices is paramount (e.g. PMs, RCM, PdM, etc.)
- Fullyproficient in understanding the functionality of all utility generationequipment (e.g. electrical distribution, clean utilities – wfi/clean steam,HVAC/R, and utility generation equipment.
- Utilityand HVAC system process improvement and optimization experience
- Technicalwriting and deviation investigation experience
- Experiencein problem solving and troubleshooting
- Familiaritywith cGMPs and vaccine/sterile regulatory requirements
Preferred Experience and Skills:
- Projectmanagement, including change control and equipment qualification
- SAPexperience related to plant maintenance and spare parts procurement systems
- cGMPexperience in a sterile, bulk or finished pharmaceutical environment
- Experiencein automation and manufacturing execution systems (MES), process modeling andprocess improvement.
- MicrosoftProject and/or Orchestrate experience
- Six Sigmagreen belt and/or black belt certification
Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we’re inventing for life.
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Employee Status: Regular
Number of Openings: 1
Shift (if applicable): 1st
Hazardous Materials: None
Company Trade Name: Merck