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Sr. Manufacturing Technical MES Systems Specialist (344937BR)

Manufacturing and Production

Manufacturing Engineer

Yearly

No

Morris Plains, New Jersey, United States

28,000 associates of more than 100 nationalities deliver high quality and affordable medicine on time, every time, safely and efficiently!<br><br>Novartis is seeking a Sr. Manufacturing Technical MES Systems Technician to join the team at our Morris Plains, NJ location. This position will be 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 AQWA.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.<br><br><br>Primary Responsibilities:<br>Design, implement, and test MES based on the Business process flow.<br>• Provide MES 24/7 support for production.<br>• Implement and maintain LIMS interactions and calculations, AQWA for<br>deviation generation during the process, and interface with SAP system<br>to issue materials to MBRs that are acceptable & released.<br>• Support the development and optimization of manufacturing processes.<br>• Configure/update MES to support change requests.<br>• Communicate with MES Global Novartis Team to ensure that local MES is<br>aligned with the Global format and structure.<br>• Properly control the release of proprietary documentation.<br>• Coordinate the review and revisions of procedures, R&D documentation<br>and FDA regulations for inclusion in Production instructions and<br>quality control manuals.<br>• Responsible for ensuring compliance with Federal, State and local<br>regulations and adherence to all company policies and procedures<br>relating to GMP’s, Health, Safety & Environmental Protection.<br>• Coordinate with IT group MES upgrades and/or changes to the system<br>for Compliance, Training, MBR changes, and User ID controls.<br>• Liaise with Subject Matter Experts, Process Experts, Validation, QA<br>and Compliance during the MBR design, creation and verification process.<br>• Support Local Master Data configuration in MES: set up of Status<br>Diagrams for objects in MES and paperless production recipes within the<br>MES system.<br>• Support the creation and update process of documentation in regards<br>to MBR design and approval, EBR execution and release.<br>• Support the creation and update of MES Business Process<br>mapping/configuration.<br>• Support the MES Operational Qualification (OQ) and Performance<br>Qualification (PQ) for the End-to-End MBR execution.<br>• Coaching & training of MBR and EBR execution process for MES Subject<br>Matter Experts, MBR Designers, and key users.<br><br>[#video#https://www.youtube-nocookie.com/embed/ggbnzRY9z8w {#400,300#}#/video#]<br>