Merck & Co.-posted 2 months ago
Full-time
Onsite • Durham, NC
Chemical Manufacturing

Are you looking for an exciting opportunity with a rapidly growing pharmaceutical manufacturer? If so, then this is the opportunity for you! The Lead Maintenance and Instrumentation Technician is responsible for providing equipment troubleshooting and maintenance support for a new product feasibility project/manufacturing support. Support updates to standard operating procedures (SOP's) and preventative maintenance (PM's) plans, as requested. Responsible for written documentation of activities. Responsible for SAP transactions and change control activities including spare part lists and Preventative Maintenance (PMs) plans. Actively supports, participates, and embraces an inclusive team culture including significant interaction with Operations, Quality, Automation, Technology, and other groups as required. Under the supervision of the Maintenance Manager, the selected candidate will utilize strong knowledge of precision measurement science (Metrology), mathematics, physics, and electronics to test, calibrate, troubleshoot, maintain and repair instrumentation/controls. All duties must be performed in compliance with established company, department, and safety policies and procedures within GXP-regulated and non-GXP facilities. The incumbent will execute daily work assignments and ensure timely completion of all scheduled and unscheduled events for instrumentation systems controls. The individual in this role will collect, compile, measure, summarize, and record data obtained during scheduled calibration and/or unscheduled work requests. This position will work in conjunction with Facilities, Engineering, Validation, Manufacturing, and Quality Control Departments to help the company and all of its personnel to reach their goals in providing a safe, clean, and efficient environment.

  • Provide equipment troubleshooting and maintenance support for new product feasibility project/manufacturing support.
  • Support updates to standard operating procedures (SOP's) and preventative maintenance (PM's) plans.
  • Responsible for written documentation of activities.
  • Responsible for SAP transactions and change control activities including spare part lists and PM plans.
  • Utilize strong knowledge of precision measurement science (Metrology), mathematics, physics, and electronics to test, calibrate, troubleshoot, maintain and repair instrumentation/controls.
  • Execute daily work assignments and ensure timely completion of all scheduled and unscheduled events for instrumentation systems controls.
  • Collect, compile, measure, summarize, and record data obtained during scheduled calibration and/or unscheduled work requests.
  • Support Process Equipment, Support Equipment, Automated Systems, Clean-In-Place Systems, and Maintenance Equipment.
  • Initiate and complete routine calibration tasks, work with and troubleshoot complex process systems.
  • Identify and resolve technical and operational problems; collaborate with peers to resolve problems that cross into inter-related units.
  • Assist in the identification, development, and implementation of new systems which enhance the operation and/or engineering processes.
  • Perform routine calibrations of instrumentation.
  • Perform maintenance, troubleshooting, repair, design, installation, and configuration of equipment, instrumentation and control systems.
  • Identify revisions, deletions, or additions to the calibration and maintenance programs.
  • Assist in the identification and selection of replacement equipment, software, and instrumentation for existing systems and equipment.
  • Perform out of tolerance reports, including reverse traceability.
  • Conduct Calibration Drift analysis and execute changes to improve calibration program.
  • Review vendor calibration certificates and maintain calibration standards.
  • Redline drawings, engineering documentation and other technical specifications.
  • Identify 'Out of Tolerance' conditions and perform corrective actions.
  • Participate with investigating and documenting the potential impact of 'Out of Tolerance' conditions.
  • Develop and/or revise calibration procedures and job plans.
  • Provide support and training to peers to improve their abilities and increase their technical knowledge.
  • Assist supervision with the assigning, scheduling and prioritization of work order requests.
  • High School Diploma/GED or higher.
  • Six (6) years of plant maintenance or equivalent Military experience with knowledge of technical craft skills (instrumentation, electrical, plumbing, advanced mechanical, HVAC, and/or multi-stage refrigeration systems).
  • Familiarity with regulatory requirements in accordance with GMP manufacturing operations.
  • Associate Degree in Industrial Systems, Mechanical, Electronics, Electrical or Instrumentation.
  • Experience working in a clean room or GMP/regulated manufacturing environment.
  • Operation, maintenance and/or troubleshooting experience with automated process equipment in the biopharmaceutical field.
  • Experience with GMP compliant calibration and/or maintenance database systems.
  • Knowledge of SAP and DeltaV and Procal.
  • Extensive calibration/instrumentation experience.
  • ASQ CCT Certification and or ISA CCST Certification (Any Level).
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