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Orca Bio

Posted 6 months ago

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Calibration Technician

SacramentoOn-site

AI Summary

The Calibration Technician inspects, tests, calibrates, and maintains measurement and test equipment to ensure accuracy and compliance with industry standards and company quality requirements.

About this role

More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.

Summary of Position: The Calibration Technician is responsible for inspecting, testing, calibrating, and maintaining measurement and test equipment to ensure accuracy and compliance with industry standards and company quality requirements. The Calibration Technician works closely with other departments to support the overall goals of the organization.

Key Responsibilities:

  • Perform calibration, adjustment, and repair of equipment used in GMP Production and Quality Control Lab testing (mechanical, electrical, electronic, and dimensional).
  • Maintain calibration records in accordance with quality standards (ISO, ANSI, NIST, etc.).
  • Utilize and maintain a Computerized Maintenance Management System (CMMS) to accurately track, plan, and document asset calibration, repairs, and inventory, ensuring data integrity for regulatory compliance.
  • Troubleshoot equipment performance issues and recommend corrective actions.
  • Ensure all Calibration Standards meet required tolerances and specifications.
  • Author and update calibration procedures.
  • Assist with internal and external audits.
  • Maintain a clean and organized calibration lab.
  • Coordinate with production and engineering teams to minimize downtime.

    • Qualifications:

  • Associate degree or technical certification in Electronics, Engineering Technology, or related field (or equivalent experience).
  • 4 years of calibration experience in a GMP environment, preferably in the cell therapy, biotechnology or pharmaceutical manufacturing facility.
  • Strong knowledge of measurement principles and standards (ISO 9001, ISO/IEC 17025 preferred).
  • Experience with Calibration Standards such as multimeters, temperature sensors pressure gauges, torque tools, tachometers, calipers, and other precision instruments.
  • Experience with GMP regulatory standards, and documenting work per GDP requirements.
  • Ability to read technical drawings and schematics.
  • Strong attention to detail, documentation, communication, and interpersonal skills.
  • Proficiency in Microsoft Office, maintenance management, and calibration management software.
  • Familiarity with NIST traceability requirements.
  • Strong problem-solving and analytical skills.
  • Ability to work independently and as part of a team.
  • The position requires on-site presence and typically involves regular hours but may require on-call availability and after-hours presence for planned or unplanned work, or emergency response.
  • Gowning for cleanroom access.
  • Ability to lift up to 40 lbs.
  • Manual dexterity for handling small components.

    • Skills

    CalibrationCalipersCMMSGMPMultimetersNIST TraceabilityPressure GaugesTachometersTemperature SensorsTorque Tools

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