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Senior. Specialist, Engineering

Job Description

Our Company & Co., Inc. Kenilworth, N.J., U.S.A. known as Our Company 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 Our Company has codified its legacy for over a century. Our Company's success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.


Our Company Manufacturing Division is a team of dedicated, energetic individuals who are committed to be 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.

GENERAL SUMMARY:

  • The Utility Engineer is a member of the Plant Engineering team providing technical support to the Durham Site. The site includes an Energy Center, Vaccines Manufacturing Facilities B101 and B102, Varicella Bulk Facility B130, Quality Labs, and Maintenance and Material Storage Facility (MMSF). This support position will focus on leading investigation of utility system excursions, system improvements and optimizations. This individual will provide input to the deviation investigation process for determination of root cause, recommend corrective actions to prevent reoccurrence 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 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 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, review contracts, supervises, and follows-up on contract work including.
  • 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

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 are needed. Engineer must be have in depth experience (without further skills training) working with industrial electrical distribution (low/medium voltages), HVAC/R systems, WFI, clean steam, utility generation equipment, and automation (BAS) systems.
  • Must be fully aware of requirement specifications from a qualification perspective (IC/OC, IQ/OQ, CRs, etc.)

FUNCTIONAL EXPERTISE:

  • Lead in the identification and implementation of process improvement projects, productivity initiatives and corrective actions while focusing on equipment uptime, minimizing cost and maintaining process consistency
  • Provide input to investigate deviations (both minor and major), with responsibility to interface with Operations, GVTE (Global Vaccine Technology), Automation, and Quality approvers.
  • As part of the deviation management role, present and defend investigations during regulatory inspections, as required.
  • Perform a thorough review of engineering records and related GMP documentation, identifying and resolving discrepancies in a timely manner, and implementing corrective actions to improve the execution/review process.
  • 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 cGMP requirements.
  • Knowledgeable of all utility systems regarding functionally of equipment and relied on as SME during regulatory discussions.

PROBLEM SOLVING:

  • 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.
  • Responsible for assisting in 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.
  • Perform engineering task as needed to maintain plant utilities equipment.

IMPACT:

  • Influence
    • Explains difficult concepts and persuades others to adopt point of view.
    • Communicates information, asks questions and checks for understanding
  • Accountability
    • Accountable for the performance of plant engineering systems and maintenance concepts
  • Decision Making
    • Makes decisions ““guided by policies, guidelines, 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

STRATEGIC PLANNING:

  • 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
  • Develops operating strategy from a utility perspective supporting site reliability initiatives.

RESOURCE MANAGEMENT:

  • Forecasts resource needs; manages allocated expense budgets
  • Forecasts resource needs; manages allocated resources to implement projects
  • Working Relationships
    • 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 uptime 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, GMP, and calibration/maintenance procedures.
    • Helps 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 Degree in Engineering, Science or related field

Required Experience and Skills:

  • 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 ““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.

Preferred Experience and Skills:

  • Project management, including change control and equipment qualification
  • SAP experience related to plant maintenance and spare parts procurement systems
  • cGMP experience in a sterile, bulk or finished pharmaceutical environment
  • Experience in automation and manufacturing execution systems (MES), process modeling and process improvement.
  • Mechincal functionality and reliability knowledge (asset management)
  • Green Belt/Black Belt Certification

Your role at Our Company 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 Our Company, we're inventing for life.

If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request tostaffingaadar@Our Company.com.

MMDHJ

Search Firm Representatives Please Read Carefully:

Our Company & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at Our Company via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Our Company. No fee will be paid in the event the candidate is hired by Our Company as a result of the referral or through other means.

Visa sponsorship is not available for this position.

For more information about personal rights under Equal Employment Opportunity, visit:

EEOC Poster

EEOC GINA Supplement

OFCCP EEO Supplement

Our Company is an equal opportunity employer, Minority/Female/Disability/Veteran ““proudly embracing diversity in all of its manifestations.

If you need an accommodation for the application process please email us at staffingaadar@merck.com

For more information about personal rights under Equal Employment Opportunity, visit:

EEOC Poster
EEOC GINA Supplement​
OFCCP EEO Supplement

OFCCP Pay Transparency Rule


We are an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.

Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

Travel Requirements:

10%

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

No

Number of Openings:

1

Requisition ID:MAI000934

Senior. Specialist, Engineering

Durham, NC
Full Time

Published on 10/07/2019