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BioFire Diagnostics, LLC. Engineering Tech in Durham, North Carolina

Position Summary & Responsibilities:

The normal working hours for this role are anticipated to be Monday - Friday from 8:00am - 5:00pm. The Reliability Engineering Technician is responsible for Reliability and troubleshooting of bioMérieux manufacturing, formulation, filling, and packaging equipment systems within the site quality management system processes.

  • Reliability of Manufacturing, Formulation, Filling, and Packaging Equipment

  • Conduct root cause analysis (RCA) and failure modes and effects analysis (FMEA) to identify and mitigate potential reliability risks for all production equipment.

  • Analyze equipment performance data to forecast potential failures and implement proactive solutions.

  • Collaborate with the maintenance team to refine preventive maintenance schedules, ensuring optimal reliability and uptime.

  • Optimize existing manufacturing processes and equipment to improve overall equipment effectiveness (OEE) and reduce mean time between failures (MTBF).

  • Utilize Six Sigma or other quality improvement methodologies to enhance equipment reliability.

  • Create and maintain detailed reliability reports and performance dashboards to monitor key reliability metrics.

  • Manage small scale projects

  • Develop and implement immediate and long term MFG continuous improvement plans.

  • Adhere to site procedures to manage service suppliers and contractor work permits during on-site activities.

  • Support large scale projects

  • Participate in commissioning and qualification activities (e.g. SAT, IQ, OQ) and conduct verification activities as required by the change control program.

  • Review and revise Manufacturing and Engineering documents for new and existing manufacturing systems.

  • Provide and document training of technical and production personnel in the application of new manufacturing systems.

    Education, Skills, & Experience:

  • High School Diploma/GED with a minimum 5 years of technical experience focused on support of manufacturing equipment with mechanical/production level equipment required.

  • Associate’s degree or higher with a minimum of 3 years of technical experience focused on support of manufacturing equipment with mechanical/production level equipment also accepted

  • 2+ years of experience working in an ISO regulated environment preferred.

  • Strong understanding of reliability engineering methodologies such as FMEA, RCA, and reliability-centered maintenance.

  • Excellent documentation and communication skills (written & verbal) within the team and external to department.

  • Position requires strong attention to detail and GMP experience.

  • Computer Skills required; must be experienced and proficient in the use of

  • Microsoft Office tools (specifically Word, Excel and PowerPoint).

  • Experience with Solidworks and AutoCAD desired

    #biojobs

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