Senior Calibration Technician

3 days ago

Thousand Oaks, California, United States FUJIFILM Corporation Full time
Job Title: Senior Calibration Technician

Overview

The Senior Calibration Technician will be responsible for the calibration of critical and non-critical equipment for the Fujifilm Diosynth Biotechnologies (FDBC) Manufacturing facility.

This position will take the lead role in maintaining, troubleshooting, and repairing equipment, instrumentation, and control systems.

The Senior Calibration Technician will apply knowledge of measurement science, mathematics, physics, and electronics to calibrate inspection, measurement, and test equipment (IM&TE).

Responsibilities
  • Perform calibration, troubleshooting, and repair of critical manufacturing equipment, cleanrooms facilities, and Quality Control Labs equipment.
  • Complete calibrations with accurate and timely GMP documentation following company SOPs.
  • Read quality control manuals and testing specifications to obtain data to test or calibrate specific devices.
  • Select, install, and troubleshoot instruments and devices.
  • Adjust calibration mechanisms to obtain specified operational performance of devices or instruments.
  • Interpret electrical schematics, I/O wiring, and panel drawings, utility, process system/equipment, and P&ID's.
  • Coordinate calibration services with third-party vendors.
  • Maintain all facilities working standards (manufacturing, utilities, and labs).
  • Use hand tools and precision measuring and calibrating instruments and equipment.
  • Interact with other departments and personnel to resolve any calibration or equipment issues.
  • Provide guidance and recommendations on selection of instruments and operational parameters.
  • Maintain a safe work environment; work in a safe manner following all safety SOP's and wear Personal Protective Equipment as required.
  • Maintain accurate records keeping equipment and systems cGMP compliant at all times.
  • Work independently and make sound judgments regarding work methods and tools.
  • Assist in the selection and monitor the performance of third-party vendors.
  • Supervise third-party vendors while performing services on the equipment. Ensure that contractors are following company and safety policies at all times.
  • Review, investigate, and report on the identification of Out of Tolerance (OOT) conditions. Assist with investigations and corrective actions to preclude the recurrence of similar issues.
  • Keep inventory of equipment critical spare parts.
  • Support investigation, change controls, or new projects.
  • Execute and/or ensure that assigned calibrations and Work Orders (WO) are completed per schedule.
  • Complete and document calibrations and work orders in the Computerized Maintenance Management System (CMMS).
Requirements
  • Broad knowledge of GMP principles, concepts, practices, and standards in the US and internationally.
  • Specific calibration and metrology training.
  • Requires the use of basic math skills and the ability to use simple gauges.
  • Ability to troubleshoot basic electrical, programmable logic controllers (PLC), plumbing systems, and problems.
  • Know how to use hand and power tools in performance of duties.
  • Good troubleshooting and problem-solving capabilities.
  • Strict attention to detail required. Problem detection ability a must.
  • Ability to act effectively as a team member to resolve problems.
  • Ability to effectively work with all functional groups.
  • Good written and verbal communication and interpersonal skills.
  • Proficient in the use of computers including a wide variety of word processing, spreadsheet software, and CMMS (Blue Mountain experience is preferred).
  • Good decision-making with strong judgment through collaboration and consideration of others' point-of-view.
  • Self-motivated, flexible, and creative leader, able to prioritize, multi-task, and work in a fast-paced and demanding environment.
  • Willing to work over-time, weekends, holidays, and on-call.
  • Role model for Fujifilm's Values.
Education/Certifications and Experience
  • 8+ years of metrology or instrumentation discipline-related experience.
  • High school diploma.
  • Relevant trade certification or some college or vocational training in engineering or utility systems preferred.
  • 4+ years of experience in a biotech or pharmaceutical company preferred.
  • Must have an excellent understanding of all safety directives and policies regarding the operation of equipment.
  • Exposure to operations involving engineering disciplines including Electrical, Mechanical, Civil, Structural, Environmental, and Industrial.
  • Mechanical knowledge of machines and tools, including their designs, uses, repair, and maintenance.

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