Manufacturing Engineering Technologist

Harba

  • Indianapolis, IN
  • Today
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    Skills

    • Asepsisunmatched
    • Biologyunmatched
    • Biotech and Pharmaceuticalunmatched
    • Continuous Improvementunmatched
    • Cross-Functionalunmatched
    • Current Good Manufacturing Practice (cGMP)unmatched
    • Data Qualityunmatched
    • Electromechanical Systemsunmatched
    • Failure Mode and Effects Analysis (FMEA)unmatched
    • GEP (Good Engineering Practices)unmatched
    • Identify Issuesunmatched
    • Instrumentationunmatched
    • Leadershipunmatched
    • Manufacturingunmatched
    • Manufacturing Engineeringunmatched
    • Manufacturing Equipmentunmatched
    • Manufacturing Operationsunmatched
    • Manufacturing Requirementsunmatched
    • Manufacturing Systemsunmatched
    • Manufacturing Technologyunmatched
    • Manufacturing/Industrial Processesunmatched
    • Medical Equipmentunmatched
    • Operations Processesunmatched
    • Preventative Maintenanceunmatched
    • Problem Solving Skillsunmatched
    • Process Control Engineeringunmatched
    • Process Failure Mode and Effects Analysis (PFMEA)unmatched
    • Process Manufacturingunmatched
    • Production Scheduleunmatched
    • Quality Assuranceunmatched
    • Requirements Managementunmatched
    • Six Sigma Certificationunmatched
    • Technical Operationsunmatched
    • Technical Supportunmatched
    • Time Managementunmatched

    Description

    Job Responsibilities:Resolve issues that arise in the day-to-day operation of manufacturing processes, providing timely responses and effective solutionsCollaborate with cross-functional technical teams and site leadership to implement process and equipment improvementsServe as a Subject Matter Expert (SME) for aseptic filling equipment and supporting manufacturing systemsEvaluate, maintain, and improve the efficiency and reliability of manufacturing instruments, equipment, and toolsSupport the implementation of new technologies, process enhancements, and operational changesParticipate in and support Process Failure Mode and Effects Analysis (FMEA) activities to identify and mitigate process and product risksProvide hands-on technical support for manufacturing activities, troubleshooting, and preventative maintenance effortsApply Good Engineering Practices (GEP) to support engineering compliance and operational excellencePartner with vendors and suppliers to define equipment requirements and review functional specificationsSupport data integrity initiatives and implementation of digital manufacturing technologiesMaintain ownership of manufacturing equipment tracking systems and related documentationDrive continuous improvement initiatives focused on quality, efficiency, and process reliabilityMentor manufacturing personnel and encourage problem-solving and solution-driven thinkingSupport production schedules through flexible work hours when necessary to ensure facility coverageQualifications:Bachelor's degree in Engineering, Life Sciences, or related technical field with 5+ years of relevant experienceOR 10+ years of relevant manufacturing engineering or technical operations experienceExperience in pharmaceutical, biologics, medical device, or other highly regulated manufacturing environmentsKnowledge of cGMP manufacturing practices and regulatory requirementsExperience with aseptic processing, sterile manufacturing, fill-and-finish operations, and process developmentStrong understanding of process controls, instrumentation, electro-mechanical systems, and manufacturing equipmentAbility to become a Subject Matter Expert (SME) for aseptic filling, inspection, and packaging equipmentLean Six Sigma certification preferred#J-18808-Ljbffr

    Numbers & Facts

    LocationIndianapolis, IN

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