MES Systems Engineer (Digital Transformation)
What Youโll Be Doing
- Support and evolve Manufacturing Execution Systems (MES) at the Indy Parenteral Manufacturing (IPM) site.
- Translate manufacturing processes into system requirements, electronic Master Batch Records (eMBRs), and MES solutions meeting quality, compliance, and operational needs.
- Support PMX MES (design, configuration, validation, deployment, and ongoing eMBR support) and help plan/execute transition to PharmaSuite.
- Work across requirements, design, testing, validation, and production support; integrate MES with manufacturing/warehouse/IT systems.
How Youโll Succeed
- Design/configure/support MES & Digital Execution solutions; troubleshoot MES, automation, and IT/network issues to reduce downtime.
- Partner with Engineering, Operations, Quality, and IT to identify root causes and implement sustainable solutions.
- Incorporate security, data integrity, and compliance into designs; communicate clearly to technical/non-technical stakeholders.
- Review/approve validation and lifecycle documentation (SOPs, protocols, system records).
What You Should Bring
- Experience with MES (PMX and/or PharmaSuite; PAS-X and/or Syncade) and ability to update system requirements/configurations and eMBRs.
- CSV experience with data integrity expectations in regulated environments.
- Hands-on troubleshooting of application behavior, interfaces, and connectivity; cross-functional collaboration.
- Awareness of secure/compliant system use; exposure to dashboards/reporting/data flows; project task tracking.
Basic Qualifications
- Bachelorโs in IT, Science, Technology Engineering, or related field.
- 1+ years IT/software/digital experience in pharmaceutical manufacturing MES (PMX/PharmaSuite/PAS-X/Syncade; WES/SAP) and manufacturing ops.
- US work authorization required.
Preferred Qualifications
- GXP/regulatory experience; maintain Computer Systems Validation (e.g., cGMP, FDA 21 CFR Part 11).
Benefits/Compensation (if applicable)
- Anticipated wage: $64,500โ$158,400. Possible company bonus and comprehensive benefits (401(k), medical/dental/vision, flexible benefits, life insurance, time off/leave, well-being benefits).