Katalyst CRO

Validation Engineer

Norwood, MA, US

5 months ago
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Summary

Responsibilities

  • Support team to investigate and resolve issues related to equipment failures, system deficiencies, deviations, and equipment troubleshooting.
  • Support authoring quality systems records such as deviations, change controls, and CAPAs as required
  • Monitor and communicate method lifecycle (acquisition, qualification/validation,
  • implementation) timelines using project management tools.
  • Ordering supplies and maintaining inventory for equipment consumables/accessories.
  • CTU alarm response, calibration, and re-qualification coordinating and scheduling.
  • Assist with locating and collecting assets due for service and returning to the laboratory when complete.
  • Train QC analysts in equipment operation.
  • Serve as the point person in QC for all equipment inquiries and relay to appropriate vendors.
  • Onsite and externally.
  • Perform as-needed non-invasive repairs on UHPLC systems such as changing capillaries, flow.
  • cells, needles/seats as well as perform basic troubleshooting.
  • Other responsibilities are to support team projects and proactive initiatives.
  • Author, revise, and maintain Equipment/Instrument SOP's.
  • Coordinate and schedule calibration/maintenance activities with Facilities, Metrology, and QC.
  • ensure timely completion minimize equipment down, and address OOT (Out of Tolerance).
  • Review preventative maintenance reports, calibration certifications, and CMMS records, and perform system inventory audits.
  • Submit asset induction, work, and administrative requests to ensure equipment failure.
  • Addressed immediately and information is CMMS is accurate and in proper state.
  • Attending cross-functional meetings.

Requirements

  • Bachelor's degree in sciences and at least 5 years of industry experience in a cGMP laboratory setting.
  • Familiar with analytical equipment troubleshooting and maintenance.
  • Strong skills with GMP/GDP/QC Data review and attention to detail.
  • Familiar with CMMS systems.
  • Technical writing skills.
  • Strong communication skills (verbal and written); Ability to collaborate effectively in a dynamic.
  • cross-functional matrix environment (QC, QA, Validation, Digital, Vendors) to ensure equipment.
  • is serviced on time.
  • Experience with CTU (Controlled Temperature Units) and equipment calibration.
  • Proficiency with Microsoft Office Programs.
  • Demonstrated ability to work effectively under established guidelines and instructions.

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