Automation Engineer
We are representing a leading cell and gene therapy CDMO that is looking to hire an Automation Engineer. The team is in active startup and ramp-up mode, with Ignition SCADA systems coming online and GMP manufacturing operations ramping toward full production readiness.ResponsibilitiesDesign, configure, and troubleshoot Ignition SCADA and HMI applications including tag mapping, Python/Jython scripting, alarm management, historian configuration, and visualization layersIntegrate Ignition with PLCs, DeltaV DCS, and vendor skids (Cytiva, Repligen) for real-time process monitoring and controlExecute FAT, SAT, and IOQ commissioning and qualification activities to bring automation systems online compliantlyOwn deviations, CAPAs, change controls, and technical documentation related to automation systems in accordance with cGMP and GDP requirementsSupport system lifecycle activities including upgrades, gateway backups, redundancy configuration, and performance monitoringCollaborate cross-functionally with operations, maintenance, engineering, and quality to drive production readinessRequirementsDesign, configure, and troubleshoot Ignition SCADA and HMI applications including tag mapping, Python/Jython scripting, alarm management, historian configuration, and visualization layersIntegrate Ignition with PLCs, DeltaV DCS, and vendor skids (Cytiva, Repligen) for real-time process monitoring and controlExecute FAT, SAT, and IOQ commissioning and qualification activities to bring automation systems online compliantlyOwn deviations, CAPAs, change controls, and technical documentation related to automation systems in accordance with cGMP and GDP requirementsSupport system lifecycle activities including upgrades, gateway backups, redundancy configuration, and performance monitoringCollaborate cross-functionally with operations, maintenance, engineering, and quality to drive production readinessRequirements5+ years of automation engineering experience with direct hands-on Ignition SCADA platform expertise requiredInductive Automation Ignition certification (Core, Gold, or Silver) strongly preferredExperience configuring SCADA and HMI applications, managing PLC integrations, and working within DeltaV DCS environmentsBackground in GMP or cGMP pharmaceutical, biotech, cell therapy, or gene therapy manufacturingExperience executing commissioning and qualification protocols including FAT, SAT, and IOQ in a regulated environmentSolid working knowledge of cGMP, GDP, 21 CFR Part 11 data integrity requirements, audit trails, user access controls, and electronic recordsFamiliarity with Cytiva or Repligen skid integration a plus***NO 3RD PARTY VENDORS***