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Key ResponsibilitiesEquipment Troubleshooting and RepairDiagnose and repair electrical, mechanical, pneumatic, and hydraulic faults on production equipment to restore uptime quickly.Support equipment such as bioreactors, CIP/SIP skids, autoclaves, lyophilizers, isolators, vial and syringe fillers, cappers, labelers, cartoners, blister lines, and case packers.Troubleshoot PLC-controlled equipment using HMIs, schematics, ladder logic, and I/O checks; work with automation on control issues.Repair or replace motors, VFDs, servo drives, gearboxes, bearings, pumps, valves, seals, conveyors, and sensors.Lead root cause analysis on repeat or major equipment failures and implement lasting fixes.Preventive and Predictive MaintenanceExecute preventive maintenance on production equipment per SOPs and the PM schedule.Perform equipment alignments, adjustments, lubrication, and changeover and format part setups.Use predictive tools such as vibration analysis, thermography, and ultrasound to catch failures early.Recommend PM improvements, spare parts levels, and reliability upgrades based on failure data.GMP Compliance and DocumentationComplete work orders and GMP documentation accurately in the CMMS (for example, SAP PM or Maximo) following ALCOA+ principles.Support deviations, CAPAs, and change controls tied to equipment.Support equipment commissioning, qualification (IQ/OQ), and startup of new or modified equipment.Follow cleanroom gowning, aseptic practices, and LOTO and safety procedures at all times.Leadership and CollaborationServe as the technical lead on equipment issues and mentor junior technicians.Partner with Manufacturing, Engineering, Quality, and Validation to plan maintenance around production schedules.Coordinate and oversee OEM service technicians and contractors.Help write and revise equipment SOPs and maintenance procedures.Required QualificationsHigh school diploma or GED plus a technical certificate or associate degree in industrial maintenance, electromechanical technology, or a related field (or equivalent military training).5+ years of hands-on equipment maintenance experience in a manufacturing environment, with at least 2 years in a GMP regulated pharmaceutical, biotech, or medical device setting.Strong electrical and mechanical troubleshooting skills on automated production equipment.Ability to read and interpret electrical schematics, P&IDs, mechanical drawings, and OEM manuals.Working knowledge of PLCs (Allen-Bradley or Siemens), HMIs, VFDs, and servo systems.Experience with a CMMS and GMP documentation practices.Working knowledge of LOTO, arc flash, and confined space safety requirements.Preferred QualificationsDirect experience on aseptic filling lines (vial, syringe, or cartridge), isolators, or lyophilizers.Experience with packaging equipment from OEMs such as Bosch/Syntegon, IMA, Uhlmann, Marchesini, or Groninger.Background supporting equipment commissioning, qualification, and new line startups.Experience with reliability practices such as RCA, FMEA, and predictive maintenance programs.Certifications such as CMRT (Certified Maintenance and Reliability Technician), vibration analysis (Level I or II), or a journeyman or state electrical license.Military maintenance or mechanical background.
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Key ResponsibilitiesEquipment Troubleshooting and RepairDiagnose and repair electrical, mechanical, pneumatic, and hydraulic faults on production equipment to restore uptime quickly.Support equipment such as bioreactors, CIP/SIP skids, autoclaves, lyophilizers, isolators, vial and syringe fillers, cappers, labelers, cartoners, blister lines, and case packers.Troubleshoot PLC-controlled equipment using HMIs, schematics, ladder logic, and I/O checks; work with automation on control issues.Repair or replace motors, VFDs, servo drives, gearboxes, bearings, pumps, valves, seals, conveyors, and sensors.Lead root cause analysis on repeat or major equipment failures and implement lasting fixes.Preventive and Predictive MaintenanceExecute preventive maintenance on production equipment per SOPs and the PM schedule.Perform equipment alignments, adjustments, lubrication, and changeover and format part setups.Use predictive tools such as vibration analysis, thermography, and ultrasound to catch failures early.Recommend PM improvements, spare parts levels, and reliability upgrades based on failure data.GMP Compliance and DocumentationComplete work orders and GMP documentation accurately in the CMMS (for example, SAP PM or Maximo) following ALCOA+ principles.Support deviations, CAPAs, and change controls tied to equipment.Support equipment commissioning, qualification (IQ/OQ), and startup of new or modified equipment.Follow cleanroom gowning, aseptic practices, and LOTO and safety procedures at all times.Leadership and CollaborationServe as the technical lead on equipment issues and mentor junior technicians.Partner with Manufacturing, Engineering, Quality, and Validation to plan maintenance around production schedules.Coordinate and oversee OEM service technicians and contractors.Help write and revise equipment SOPs and maintenance procedures.Required QualificationsHigh school diploma or GED plus a technical certificate or associate degree in industrial maintenance, electromechanical technology, or a related field (or equivalent military training).5+ years of hands-on equipment maintenance experience in a manufacturing environment, with at least 2 years in a GMP regulated pharmaceutical, biotech, or medical device setting.Strong electrical and mechanical troubleshooting skills on automated production equipment.Ability to read and interpret electrical schematics, P&IDs, mechanical drawings, and OEM manuals.Working knowledge of PLCs (Allen-Bradley or Siemens), HMIs, VFDs, and servo systems.Experience with a CMMS and GMP documentation practices.Working knowledge of LOTO, arc flash, and confined space safety requirements.Preferred QualificationsDirect experience on aseptic filling lines (vial, syringe, or cartridge), isolators, or lyophilizers.Experience with packaging equipment from OEMs such as Bosch/Syntegon, IMA, Uhlmann, Marchesini, or Groninger.Background supporting equipment commissioning, qualification, and new line startups.Experience with reliability practices such as RCA, FMEA, and predictive maintenance programs.Certifications such as CMRT (Certified Maintenance and Reliability Technician), vibration analysis (Level I or II), or a journeyman or state electrical license.Military maintenance or mechanical background.
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Harba Solutions Inc. • Raleigh, North Carolina
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