About this role
This role is a senior manufacturing automation position supporting a facility and the Modality Agnostic Chemistry Scaleup (MACS) Center. You will lead automation system work including design, commissioning/qualification, troubleshooting, reliability improvements, cybersecurity hardening, and GMP documentation to enable facility startup and operations.
Key Responsibilities
- Troubleshoot automation and instrumentation issues and perform root cause analysis
- Implement corrective/preventive actions to improve reliability, safety, and energy performance
- Develop deployment strategies for facility systems
- Manage system patches, firmware upgrades, backup/restore, and cybersecurity hardening
- Ensure data integrity, audit trails, and GMP documentation (including test documentation)
Technical Overview
You will support automation equipment and software design, then execute system commissioning and qualification for GMP-relevant manufacturing facilities. The role includes managing patches and firmware, backup/restore, cybersecurity hardening, and enforcing data integrity and audit trails, while leading capital project automation installation and test documentation.
Ideal Candidate
The ideal candidate is a senior manufacturing automation engineer/automation SME who can support facilities under construction by handling automation equipment and software design, commissioning/qualification, and startup-critical automation work. They have strong troubleshooting and root cause analysis experience, and they ensure data integrity, audit trails, and GMP documentation compliance while managing patches, firmware, backups, and cybersecurity hardening.
Must-Have Skills
troubleshoot automation and instrumentation issuesperform root cause analysisimplement corrective/preventive actionssystem commissioning/qualificationmanage system patchesfirmware upgradesbackup/restore strategiesand cybersecurity hardeningensure robust data integrity and audit trails suitable for operationswritereview or execute test documentationauthoring of GMP documentation
Tools & Platforms
GMP documentation
Required Skills
manufacturing automationautomation equipment designautomation software designsystem commissioning/qualificationtroubleshooting automation and instrumentationroot cause analysiscorrective and preventive actionsdeployment strategiessystem patchesfirmware upgradesbackup/restore strategiescybersecurity hardeningdata integrityaudit trailscapital projectsdesign install and commissiontest documentationGMP documentationMACS Center
Hard Skills
manufacturing automationautomation engineerautomation equipment designautomation software designsystem commissioning/qualificationGMP documentationtroubleshoot automation and instrumentation issuesroot cause analysiscorrective actionspreventive actionsdeployment strategies for systems in the facilitysystem patchesfirmware upgradesbackup/restore strategiescybersecurity hardeningcorporate cybersecurity policiesdata integrityaudit trailscapital projectsdesign install and commission new equipmenttest documentationmodality agnostic chemistry scaleup (MACS) Centersmall molecule process research & development (SM PR&D) networkautomation system assetsutility systemsinfrastructurecompliance representatives
Soft Skills
technical leadershipcollaborationcross-functional collaboration with development engineers and chemistsability to foster a culture of collaborationlearning and innovationstakeholder coordinationproblem-solvinglearning mindset
Keywords for Your Resume
Senior SpecialistManufacturing Automation Engineerautomation engineerautomation and instrumentation issuesroot cause analysiscorrective/preventive actionsdeployment strategiessystem patchesfirmware upgradesbackup/restore strategiescybersecurity hardeningdata integrityaudit trailscapital projectsdesign install and commissiontest documentationGMP documentationModality Agnostic Chemistry Scaleup (MACS) CenterSmall Molecule Process Research & Development (SM PR&D) networkModality Agnostic Chemistry Scaleup (MACS)manufacturing automation engineersystem commissioning/qualification
Deal Breakers
Must be able to write, review or execute test documentation, Must demonstrate experience ensuring data integrity and audit trails suitable for operations, Must have hands-on responsibility for GMP documentation authoring
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