Specialist Engineering

MSD Malaysia

Durham (NC)

On-site

USD 87,000 - 137,000

Full time

3 days ago
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Benefits offered by this job

Medical
Dental
Vision healthcare and other insurance
401(k) retirement benefits
Paid holidays
Vacation
Compassionate and sick days

Job summary

Merck & Co., Inc. in the United States invites applications for a Senior Mechanical Services Engineer to ensure reliable equipment performance through hands-on maintenance support, complex troubleshooting, and investigations.

You will align maintenance projects with Safety, Compliance and Cost objectives and identify improvement opportunities with minimal supervision. The role involves calibration/maintenance program improvements, root cause analysis, CMMS data integrity, and collaboration with

Qualifications

  • Minimum of two years’ in a production and/or calibration and/or maintenance background.
  • Strong planning, scheduling, and time management skills.
  • Working knowledge of regulatory requirements in accordance with GMP manufacturing operations.
  • Good oral and written communication skills.
  • Experience with GMP compliant calibration and maintenance databases.
  • Project management experience including change control and equipment qualification cGMP experience in a sterile, bulk or finished pharmaceutical environment.

Responsibilities

  • Analyzes calibration, maintenance, and equipment performance and work orders to identify trends with an emphasis on reducing reactive work and increasing reliability
  • Identifies revisions, deletions, or additions to the calibration and maintenance programs and SOPs to ensure calibration and maintenance activities comply with safety and calibration procedures
  • Collaborates with Operations, Technology, Automation, and Quality Approvers to determine the scope of investigations, identify root cause, implement corrective actions, and trend product disposition
  • Leads deviation investigations for instruments, equipment, and system failures with timely documentation
  • Leads PM optimization and continuous improvement projects focusing on uptime and cost efficiency

Education

Bachelor’s Degree or higher in Engineering, Science or related field

Tools

CMMS
Calibration Databases
Maintenance Databases

Job description

Position Description

The Mechanical Services Engineer position will ensure the reliable performance of equipment during by provide hands‑on maintenance support for complex troubleshooting and repairs of equipment, as well as supporting Technology and Quality during equipment investigations and modifications. The successful candidate will be responsible for aligning maintenance projects with the business objectives around Safety, Compliance and Cost. The Senior Mechanical Services Engineer must be able to self‑identify opportunities for improvement and execute with minimal supervision.

Responsibilities
  • Analyzes calibration, maintenance, and equipment performance and work orders to identify trends with an emphasis on reducing reactive work and increasing reliability
  • Identifies revisions, deletions, or additions to the calibration and maintenance programs and Standard Operating Procedures (SOP’s) to ensure that calibration and maintenance activities are completed in accordance with established safety, GMP, and calibration/maintenance procedures
  • Work with the Operations, Technology, Automation, and Quality Approvers to determine the breadth and scope of the investigation to identify the appropriate root cause, implement corrective actions, complete trending analysis, and determine product disposition
  • Helps establish processes that ensure required Safety guidelines are followed and participates in divisional Safety Audit activities
  • Leads deviation investigations for instruments, equipment, and system failures, ensuring events are well‑investigated and well‑documented, while meeting timing commitments
  • 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
  • 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
  • Support safety programs (LOTO, HECP, etc.) and environmental compliance from a maintenance perspective
  • Collaborates with the production area maintenance technicians and engineers to maintain all production equipment
  • Collaborates with the Technical CoE Reliability Engineers to conduct periodic RBAM assessments and own area specific reliability actions
  • Ensure accurate BOMs and Equipment information in CMMS
  • Ensure adequate job plans for PMs and/or Calibrations
  • Adequate skill set assigned for task
  • Correct plan hours listed on CMMS
  • Understand criticability of instruments and/or equipment
  • Manage RBAM, CAPAs, and any other actions related to his area equipment
  • Perform root cause analysis and implement preventive actions.
  • Ensure accuracy of HECP and Safety procedures.
  • Maintain Uptime performance over 90%
  • Ensure accurate MTTR and MTBF data collection
  • Familiarize with the Reliability Engineer for Maintenance elements (RCM, FMEA, CA, PMO, RCA, RE, CP)
  • Respond to calls off hours including weekends and nights when equipment in their area of responsibility fails
  • Collaborate with the Maintenance Planner when establishing corrective work orders
  • Establish and lead the condition monitoring strategy of the equipment (use of PI, Vibration, Ultrasound, Infrared, Motor Testing, Balancing, Non Destructive Testing, Machinery Lubrication)
  • Establish a Defect Elimination Process
  • Establish metrics (KPIs) to improve equipment performance
  • Identify reliability improvement projects
  • Prepare training for mechanics and instrumentation technicians
  • Subject Matter Expert (SME) of assigned area equipment
  • Participate in FMEA activities
  • Lead PM Optimization activities
  • Knowledgeable of the Reliability Engineer for Maintenance elements (RCM, FMEA, CA, PMO, RCA, RE, CP)
  • Reliability: Fix it before it fails
  • Defect Elimination: Activities directed by management
  • Feedback Loops: anticipation of failure tells you what to work on
  • Lead equipment failure investigation
Education

Bachelor’s Degree or higher in Engineering, Science or related field

Required

Minimum of two years’ in a production and/or calibration and/or maintenance background

  • Strong planning, scheduling, and time management skills
  • Working knowledge of regulatory requirements in accordance with GMP manufacturing operations
  • Good oral and written communication skills
  • Experience with GMP compliant calibration and maintenance databases
  • Project management experience including change control and equipment qualification cGMP experience in a sterile, bulk or finished pharmaceutical environment
Preferred
  • Experience with formal problem solving techniques, such as root cause analysis (RCA), failure mode effects analysis (FMEA), and/or Lean Six Sigma tools
  • Experience in automation and manufacturing execution system (MES), process modeling and process improvement
  • Experience in deviation management, troubleshooting and resolving manufacturing anomalies
Required Skills
  • Adaptability, Adaptability
  • Computerized Maintenance Management Systems (CMMS)
  • Corrective Action Management
  • Critical Thinking
  • Data Analysis
  • Driving Continuous Improvement
  • Electrical Systems
  • Engineering Design
  • Equipment Maintenance
  • Equipment Troubleshooting
  • Failure Analysis
  • FMECA
  • Maintenance Engineering
  • Manufacturing Execution Systems (MES)
  • Manufacturing Maintenance
  • Manufacturing Processes
  • Mechanical Troubleshooting
  • Overall Equipment Effectiveness (OEE)
  • Process Improvements
  • Regulatory Compliance
  • Reliability Engineering
  • Root Cause Analysis (RCA)
  • Root Cause Identification
  • Root Cause Investigations
Skills
  • Adaptability
  • Computerized Maintenance Management Systems (CMMS)
  • Corrective Action Management
  • Critical Thinking
  • Data Analysis
  • Driving Continuous Improvement
  • Electrical Systems
  • Engineering Design
  • Equipment Maintenance
  • Equipment Troubleshooting
  • Failure Analysis
  • FMECA
  • Maintenance Engineering
  • Manufacturing Execution Systems (MES)
  • Manufacturing Maintenance
  • Manufacturing Processes
  • Mechanical Troubleshooting
  • Overall Equipment Effectiveness (OEE)
  • Process Improvements
  • Regulatory Compliance
  • Reliability Engineering
  • Root Cause Analysis (RCA)
US and Puerto Rico Residents Only

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts

Salary

The salary range for this role is $87,300.00 - $137,400.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long‑term incentive, if applicable.

Benefits
  • Medical
  • Dental
  • Vision healthcare and other insurance benefits (for employee and family)
  • Retirement benefits, including 401(k)
  • Paid holidays
  • Vacation
  • Compassionate and sick days

More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

Employment Details

Employee Status: Regular Relocation: Domestic VISA Sponsorship: No Travel Requirements: 10% Flexible Work Arrangements: Not Applicable Shift: 1st - Day, 2nd - Evening, 3rd - Night Valid Driving License: No Hazardous Material(s): N/A Job Posting End Date: 09/1/2026 *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.

Other Information

San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment 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, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, 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.

Our company 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 we have codified our legacy for over a century. Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.

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