MES Administrator – Sterile Injectables & Packaging
Technical specialist responsible for administration, configuration, and support of MES across sterile manufacturing and packaging operations. The role ensures system availability, compliant electronic execution, and support for ongoing MES expansion activities.
Responsibilities
- Provide daily technical administration and second-level MES support
- Troubleshoot system issues across application, configuration, and integration layers
- Maintain MES master data including equipment models, recipes, workflows, and security roles
- Implement configuration updates through formal change control processes
- Support live Weigh and Dispense operations ensuring accurate material traceability
- Investigate and resolve issues relating to dispensing activities and barcode usage
- Support deviations, investigations, and data review activities linked to MES processes
- Configure and maintain MES execution for compounding, aseptic filling, washrooms, depyrogenation, and packaging lines
- Support electronic batch record execution and phased MES deployment activities
- Participate in system design, testing, validation, and go-live support for manufacturing areas
- Support MES integration with ERP, automation systems, printers, mobile devices, and packaging equipment
- Assist with CSV lifecycle activities including documentation review and qualification testing
- Ensure MES compliance with GMP, data integrity standards, and regulatory expectations
- Provide technical support during internal audits and regulatory inspections
Requirements
- Qualification in Engineering, IT, Automation, Computer Science, or related discipline
- Experience supporting MES within GMP-regulated manufacturing environments
- Strong understanding of sterile injectables production and packaging processes
- Exposure to Weigh and Dispense, electronic batch records, eLogs, or packaging execution systems
- Hands-on MES configuration and master data management experience
- Knowledge of shop-floor automation, equipment integration, and packaging line controls
- Understanding of validation, change control, deviation management, and audit support
- Experience with aseptic filling or packaging lines is advantageous
- Previous involvement in MES implementation or expansion projects is desirable
- Familiarity with printing, vision inspection, or serialization technologies is beneficial
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