Senior MES Systems Specialist
About the Role
About the role:
Responsible for the design, implementation, and verification of electronic Master Batch Records (MBRs) and provide oversight and execution for the Manufacturing Execution System (MES) which will automate much of the record keeping, information flow and documentation for Morris Plains Cell Processing Operations. This includes paperless manufacturing instructions, paperless in process control, enforcing process sequencing and electronic go/no go decisions, process validation ranges, formulas to ensure the final yield is within acceptable percentages, and interface with the various systems in place including SAP, LIMS, and 1QEM. This role requires strong collaboration with the GMP Documentation Coordinator role within Operations to ensure priorities are being addressed in a timely manner to meet CTL019 and other Product Launch timelines.
Your Key Responsibilities:
•Design, implement, and test MES based on the Business process flow.
•Provide MES 24/7 support for production for troubleshooting purposes
•Implement and maintain LIMS interactions, 1QEM for deviation generation during the process, interface with SAP system to issued materials to MBRs and other potential future systems that are interfaced with MES. Ensure they are acceptable & released as required.
•Support the development and optimization of manufacturing processes.
•Configure/update MES to support change requests
•Own and Support Change Controls related to MES
•Own CAPAs related to MES updates
•Represent MES in local/global SPOC and CCRB
•Provide departmental evaluations for changes
•Ensure all MES MBR revisions are aligned with
timelines to meet required CR updates
•Coordinate with IT group MES upgrades and/or changes to the system for Compliance, Training, MBR changes, and User ID controls and support any system qualification needs.
•Liaise with Subject Matter Experts, Process Experts, Validation, QA and Compliance during the MBR design, creation and verification process.
•Support Local Master Data configuration in MES and the creation and update of MES Business Process mapping/configuration.
•Support the creation and update process of documentation in regards to MBR design and approval, EBR execution and release.