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Specialist Engineering

Merck

Durham (Old Oxford), NC, US$87k – $137konsite

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About this role

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

This position is a 1st shift position with the potential for infrequent off shift work and weekend work as needed to support business results.  This position is expected to work as an independent member of an integrated team focused on achieving the team’s objectives, vision, and goals

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 #VetJobs #EBRG's #MSJR

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,

Salary insight

The midpoint of this range ($112k) is about 14% below the median disclosed salary for Raleigh-Durham roles listed on ForgeApply ($130k across 407 jobs).

Based on live postings with disclosed pay on ForgeApply; refreshed daily. Not an estimate of this employer's offer.

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