Hikma Pharmaceuticals USA Inc.

  • Instrumenation/Calibration Technician

    Job Location US-NJ-Cherry Hill
    Posted Date 3 months ago(5/24/2018 1:15 PM)
    Job ID
    2018-4546
    Job Function
    Maintenance
    Shift
    2nd
  • Overview

    This is position located in Cherry Hill, NJ on 2nd Shift

     

    Perform scheduled services and advanced level troubleshooting/service of unscheduled and scheduled critical calibrations on process control equipment associated with production equipment, incubators, freezers, clean steam generators, WFI systems, autoclaves, sterilization equipment, etc. to NIST and GMP Standards. Possess in-depth technical knowledge requirements for performing calibration and repair of various instruments including incubators, freezers, clean steam generators, WFI systems, autoclaves, Experience working in mechanical and clean rooms desired.

    Responsibilities

    1. Document all work performed to ensure compliance with Good Manufacturing Practices (GMP) and other applicable Food and Drug Association (FDA) regulations
    2. Recognize out of tolerance conditions and initiate corrective action and documentation. Record and report abnormal function of equipment or out of tolerance conditions and initiate corrective action
    3. Assist in the evaluation of cost saving opportunities via internalization of tasks, parts reconditioning and the changing of vendors
    4. Assist in training other technicians
    5. Perform calibration and functional checks using a combination of temperature, pressure, level, flow, pH and other standards
    6. Perform advanced level repairs/upgrades/troubleshooting beyond what is accomplished during a routine calibration or preventive maintenance or service
    7. Provide technical support for developing and writing instrument procedures relating to calibration, calibration limits and interval assessment, preventive maintenance or other documentation for pharmaceutical services
    8. Communicate with customer staff, OEMs, and outside contractors in the calibration, repair and operation of equipment necessary and coordinates with outside contractors regarding repairs covered by maintenance agreements
    9. Comply with company policies and procedures and adhere to company standards
    10. Perform work in accordance with approved equipment calibration, maintenance and safety procedures
    11. Perform Lock Out / Tag Out, Confined Space Entry, Job Hazard Analysis, and follow all CBRE and client safety policies
    12. Troubleshoot various processes and equipment interfacing with the Environmental Monitoring System (EMS) and Building Automation System
    13. Read instrument loop sheets, equipment manuals, electrical drawings and schematics
    14. Work closely with Maintenance and Operations personnel in attaining production goals and objectives
    15. Must be able to work all shifts including weekends and holidays
    16. Must be able to be gowned qualified and maintain gowning status.
    17. Perform other duties as required.

    Qualifications

    Associates degree preferred. Three years of instrumentation and calibration experience preferred.Understanding of FDA regulations and GMP's

    1. Ability to comprehend and interpret instructions, short correspondence, and memos and ask clarifying questions to ensure understanding.
    2. Ability to write routine reports and correspondence.
    3. Ability to respond to common inquiries co-workers, and/or supervisor.
    4. Knowledge and capability to perform daily work activities with computer programs such as CMMS work order data base system, Microsoft Office including Outlook, Word, and Excel.
    5. Must be physically able to perform basic maintenance tasks to the highest caliber, which includes ability to lift objects weighting up to 50 lbs.
    6. Must be a team player committed to working in a quality environment.
    7. Experience specific to the pharmaceutical Industry preferred.

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