MSD-posted 2 months ago
Full-time • Mid Level
Bahama, NC
5,001-10,000 employees

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. Responsible for supporting: Process Equipment (e.g. tanks/bioreactors, filtration skids, chromatography columns) Support Equipment (e.g. washers, autoclaves, tube welders/sealers, WFI stills, Clean steam generation) Automated Systems (e.g. Distributed Control System (DCS), Programmable Logic Controllers (PLC), robotics, Building Automation System (BAS)) Clean-In-Place (CIP) Systems Maintenance Equipment (e.g. tools and calibration equipment) Support to Digital Platforms (e.g. SAP, ProCal, Brady) Initiate and complete routine calibration tasks, work with and troubleshoot complex process systems Contributes to the performance and results of the department Identifies and resolves technical and operational problems; collaborates with peers to resolve problems that cross into inter-related units Assisting in the identification, development, and implementation of new systems which enhances the operation and/or engineering processes Decisions are guided by policies, procedures, and business plan; receives guidance from manager Strong knowledge of instrumentation, PLCs and electronic and pneumatic loop control systems within the following disciplines: Conductivity, Low Frequency Electromagnetic Flow, Level, Mechanical, Optical, pH, Pressure, Temperature, Time, Speed and Weight. Perform routine calibrations of instrumentation. Perform maintenance, troubleshooting, repair, design, installation, and configuration of equipment, instrumentation and control systems. Identifies revisions, deletions, or additions to the calibration and maintenance programs to ensure that calibration and maintenance activities are carried out in accordance with established safety, GMP, and calibration/maintenance procedures. Assist in the identification and selection of replacement equipment, software, and instrumentation for existing systems and equipment. Perform out of tolerance reports, which may include doing reverse traceability. Calibration Drift analysis and executing changes to improve calibration program. Propose calibration equipment upgrade requirement when needed in order to be in compliance and up to date with calibration orders. Review’s vendor calibration certificates. Maintains calibration standards Redline drawings, engineering documentation and other technical specifications Identify “Out of Tolerance” conditions and perform corrective actions to return the device to within specification. Participate with investigating and documenting the potential impact that the “Out of Tolerance” condition may have had on the instrumentation and process. Develop and/or revise calibration procedures and job plans while looking for ways to improve how calibrations and troubleshooting is performed in an attempt to make those practices more efficient. Provide support and training to peers to improve their abilities and increase their technical knowledge Assists supervision with the assigning, scheduling and prioritization of work order requests using maintenance management systems. Must be flexible to perform all the following functions and other tasks, as needed: Ability to work with and troubleshoot complex process systems to include bioreactors, filtration skids, chromatography columns, washers, autoclaves, and CIP skids. Testing, adjustment, maintenance, repair, calibration and troubleshooting of complex automated process equipment. Support updates of standard operating procedures (SOPs), preventative maintenance (PM) plans/calibration procedures, task lists, etc., as required. Identify spare parts for preventive maintenance plans. Interface with other departments, contractors and disciplines on scheduling repairs and maintenance of clean utility systems Assists with execution of automation, validation, and additional testing, as required Responsible for written documentation of activities Completes preventative maintenance and calibration work orders, resolves deviations, and evaluates equipment performance for efficient operation. Efficient and safe maintenance and repair of equipment using Hazardous Energy Control Procedures Compliance with current good manufacturing procedures(cGMP), safety and environmental requirements/regulations/guidelines Effective maintenance, troubleshooting, and problem-solving skills required Ability to manage multiple priorities and advance several tasks in parallel Demonstrated instrumentation aptitude Proficient in the use of general hand and power tools, instruments and testing apparatus commonly used in maintenance and instrumentation. Ability to read P&ID's, electrical drawings, blueprints, etc. Routine shift will be 2-2-3, 12-hour day shift schedule, including holidays and alternating weekends. Successful candidate will be required to work an 8-hour weekday schedule until shift is required. Must possess good organizational, communication and time management skills, with a strong attention to detail, be able to follow Standard Operating Procedures, Calibration Procedures, and work instructions. Must be self-motivated, able to work both independently and as part of a team with strict adherence to all environmental, health and safety policies and procedures. Candidates must have good comprehension and work experience using calibration principals, along with basic computer skills. Broad spectrum of calibration and process control experience involving but not limited to Conductivity, Flow, Level, pH, Pressure, Temperature, Speed and Weight, RH, Gas Concentrations, Electrical, etc. "Self-starter" attitude and ability to learn and understand new equipment or instrumentation.

  • 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.
  • 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.
  • 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.
  • Initiate and complete routine calibration tasks, work with and troubleshoot complex process systems
  • Contributes to the performance and results of the department
  • Identifies and resolves technical and operational problems; collaborates with peers to resolve problems that cross into inter-related units
  • Assisting in the identification, development, and implementation of new systems which enhances 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.
  • Identifies revisions, deletions, or additions to the calibration and maintenance programs to ensure that calibration and maintenance activities are carried out in accordance with established safety, GMP, and calibration/maintenance procedures.
  • Assist in the identification and selection of replacement equipment, software, and instrumentation for existing systems and equipment.
  • Perform out of tolerance reports, which may include doing reverse traceability.
  • Calibration Drift analysis and executing changes to improve calibration program.
  • Propose calibration equipment upgrade requirement when needed in order to be in compliance and up to date with calibration orders.
  • Review’s vendor calibration certificates.
  • Maintains calibration standards
  • Redline drawings, engineering documentation and other technical specifications
  • Identify “Out of Tolerance” conditions and perform corrective actions to return the device to within specification.
  • Participate with investigating and documenting the potential impact that the “Out of Tolerance” condition may have had on the instrumentation and process.
  • Develop and/or revise calibration procedures and job plans while looking for ways to improve how calibrations and troubleshooting is performed in an attempt to make those practices more efficient.
  • Provide support and training to peers to improve their abilities and increase their technical knowledge
  • Assists supervision with the assigning, scheduling and prioritization of work order requests using maintenance management systems.
  • Testing, adjustment, maintenance, repair, calibration and troubleshooting of complex automated process equipment.
  • Identify spare parts for preventive maintenance plans.
  • Interface with other departments, contractors and disciplines on scheduling repairs and maintenance of clean utility systems
  • Assists with execution of automation, validation, and additional testing, as required
  • Completes preventative maintenance and calibration work orders, resolves deviations, and evaluates equipment performance for efficient operation.
  • Efficient and safe maintenance and repair of equipment using Hazardous Energy Control Procedures
  • High School Diploma/GED or higher and 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)
  • Required Experience and Familiarity of regulatory requirements in accordance with GMP manufacturing operations
  • Strong knowledge of instrumentation, PLCs and electronic and pneumatic loop control systems within the following disciplines: Conductivity, Low Frequency Electromagnetic Flow, Level, Mechanical, Optical, pH, Pressure, Temperature, Time, Speed and Weight.
  • Decisions are guided by policies, procedures, and business plan; receives guidance from manager
  • Compliance with current good manufacturing procedures(cGMP), safety and environmental requirements/regulations/guidelines
  • Effective maintenance, troubleshooting, and problem-solving skills required
  • Ability to manage multiple priorities and advance several tasks in parallel
  • Demonstrated instrumentation aptitude
  • Proficient in the use of general hand and power tools, instruments and testing apparatus commonly used in maintenance and instrumentation.
  • Ability to read P&ID's, electrical drawings, blueprints, etc.
  • Must possess good organizational, communication and time management skills, with a strong attention to detail, be able to follow Standard Operating Procedures, Calibration Procedures, and work instructions.
  • Must be self-motivated, able to work both independently and as part of a team with strict adherence to all environmental, health and safety policies and procedures.
  • Candidates must have good comprehension and work experience using calibration principals, along with basic computer skills.
  • Broad spectrum of calibration and process control experience involving but not limited to Conductivity, Flow, Level, pH, Pressure, Temperature, Speed and Weight, RH, Gas Concentrations, Electrical, etc.
  • "Self-starter" attitude and ability to learn and understand new equipment or instrumentation.
  • 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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