Specialist Engineering

About the role

The Mechanical Services Engineer ensures the reliable performance of equipment by providing hands-on maintenance support for complex troubleshooting and repairs, as well as supporting Technology and Quality during equipment investigations and modifications. The successful candidate will align maintenance projects with business objectives around Safety, Compliance, and Cost, self-identify opportunities for improvement, and execute with minimal supervision.

Responsibilities

• Analyzes calibration, maintenance, and equipment performance and work orders to identify trends, emphasizing reducing reactive work and increasing reliability.
• Identifies revisions, deletions, or additions to calibration and maintenance programs and Standard Operating Procedures (SOPs) to ensure compliance with safety, GMP, and calibration/maintenance procedures.
• Collaborates with Operations, Technology, Automation, and Quality Approvers to determine the scope of investigations, identify root causes, implement corrective actions, complete trending analysis, and determine product disposition.
• Helps establish processes to ensure required Safety guidelines are followed and participates in divisional Safety Audit activities.
• Leads deviation investigations for instruments, equipment, and system failures, ensuring thorough documentation and timely completion.
• Leads the identification and implementation of process improvement projects, productivity initiatives, and corrective actions, focusing on equipment uptime, cost minimization, and process consistency.
• Develops training materials and provides necessary training as a subject matter expert (SME) for system maintenance.
• Works alongside operations and Lean Six Sigma teams to develop reliable, consistent manufacturing processes that meet cGMP requirements.
• Supports safety programs (LOTO, HECP, etc.) and environmental compliance from a maintenance perspective.
• Collaborates with production area maintenance technicians and engineers to maintain all production equipment.
• Works with Technical CoE Reliability Engineers to conduct periodic RBAM assessments and own area-specific reliability actions.
• Ensures accurate BOMs and equipment information in CMMS.
• Ensures adequate job plans for PMs and/or Calibrations, including skill sets assigned for tasks and correct plan hours listed in CMMS.
• Understands the criticality of instruments and/or equipment.
• Manages RBAM, CAPAs, and other actions related to area equipment.
• Performs root cause analysis and implements preventive actions.
• Ensures accuracy of HECP and Safety procedures.
• Maintains uptime performance over 90%.
• Ensures accurate MTTR and MTBF data collection.
• Familiarizes with Reliability Engineer for Maintenance elements (RCM, FMEA, CA, PMO, RCA, RE, CP).
• Responds to off-hours calls, including weekends and nights, when equipment in their area of responsibility fails.
• Collaborates with the Maintenance Planner when establishing corrective work orders.
• Establishes and leads the condition monitoring strategy of equipment (use of PI, Vibration, Ultrasound, Infrared, Motor Testing, Balancing, Non-Destructive Testing, Machinery Lubrication).
• Establishes a Defect Elimination Process.
• Establishes metrics (KPIs) to improve equipment performance.
• Identifies reliability improvement projects.
• Prepares training for mechanics and instrumentation technicians.
• Serves as Subject Matter Expert (SME) for assigned area equipment.
• Participates in FMEA activities.
• Leads PM Optimization activities.
• Leads equipment failure investigations.

Requirements

• Bachelor’s Degree or higher in Engineering, Science, or related field.
• Minimum of two years in a production, 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 Qualifications

• 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.

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)
• Root Cause Identification
• Root Cause Investigations

Schedule

This is a 1st shift position with the potential for infrequent off-shift work and weekend work as needed to support business results. Travel requirements are 10%.

Pay

The salary range for this role is $87,300.00 - $137,400.00. An employee’s position within the salary range will be based on 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

• Comprehensive medical, dental, and 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 Merck Compensation and Benefits.