Specialist Engineering

MSD•Durham, NC

5d•$87,300 - $137,400•Onsite

About The Position

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. 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

Requirements

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

Nice To Haves

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

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