About this role
Specialist-level manufacturing automation role supporting a GMP facility startup and the MACS Center. The position focuses on automation equipment/software design, commissioning/qualification, troubleshooting, and compliance documentation for enabling facilities operations.
Key Responsibilities
- Troubleshoot automation and instrumentation and perform root cause analysis
- Develop, test, and deploy logic graphics
- Manage patches, firmware upgrades, backup/restore, and cybersecurity hardening
- Ensure data integrity and audit trails
- Support capital projects (design, install, commission; write/review/execute test documents)
Technical Overview
Own technical SME responsibilities for manufacturing automation in a GMP environment, including logic graphics development/deployment, automation commissioning/qualification, automation and instrumentation troubleshooting with root-cause and CAPA, and automation system administration tasks (patches, firmware upgrades, backup/restore, cybersecurity hardening) with data integrity and audit trail compliance.
Ideal Candidate
The ideal candidate is a manufacturing automation engineer who can act as a technical SME for automation systems in a GMP clinical manufacturing environment. They have hands-on experience with commissioning/qualification, troubleshooting and root-cause analysis, and they can develop and deploy automation logic graphics while ensuring data integrity and audit trails. They are comfortable supporting capital projects, managing patches/firmware and cybersecurity hardening, and contributing to GMP documentation.
Must-Have Skills
Automation engineering (Specialist level)Troubleshoot automation and instrumentation issuesPerform root cause analysisImplement corrective/preventive actions (CAPA)Developtestand deploy logic graphicsManage system patches and firmware upgradesEnsure robust data integrity and audit trailsSupport capital projects (designinstallcommission)Provide on-call support rotationAuthor GMP documentationWork with compliance representatives
Required Skills
Manufacturing automationAutomation engineeringautomation equipment and software designsystem commissioningsystem qualificationtroubleshooting automation and instrumentationroot cause analysiscorrective/preventive actions (CAPA)logic graphicssystem patchesfirmware upgradesbackup/restore strategiescybersecurity hardeningdata integrityaudit trailscapital projectstest documentson-call support rotationGMP documentation authoringchange management
Hard Skills
Manufacturing automationAutomation engineeringAutomation equipment and software designSystem commissioningSystem qualificationAutomation system troubleshootingRoot cause analysisCorrective and preventive actions (CAPA)Logic graphics developmentSystem patch managementFirmware upgradesBackup and restore strategiesCybersecurity hardeningData integrityAudit trailsTest documentsTest document executionTest document reviewTest document writingCapital projects supportGMP documentation authoringChange managementOn-call support rotationInstrumentation issues troubleshootingEnergy performance improvementSafety improvement
Soft Skills
Technical subject matter expert (SME)CollaborationLearning mindsetInnovation mindsetCross-functional collaborationProject managementCommunicationTroubleshooting mindsetOwnership
Keywords for Your Resume
Manufacturing Automation EngineerSpecialist - Manufacturing AutomationAutomation engineertechnical SMEModality Agnostic Chemistry Scaleup (MACS) CenterMACS Center designcommissioningqualificationautomation equipment and software designsystem commissioning/qualificationtroubleshoot automation and instrumentationroot cause analysiscorrective/preventive actionslogic graphicssystem patchesfirmware upgradesbackup/restorecybersecurity hardeningdata integrityaudit trailsGMP documentationchange managementon-call support rotationcapital projectstest documentsautomation engineer
Deal Breakers
Must be able to troubleshoot automation and instrumentation issues, Must be able to ensure data integrity and audit trails suitable for operations, Must support commissioning/qualification activities for facility startup
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