Validation Engineer - Katalyst Healthcares & Life Sciences

• 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.