Mfg Technical MES System Specialist

Job description

Job Description

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, enforces process sequencing and electronic go/no go decisions, process validation ranges, formulas to ensure the final yield is within acceptable percentages, interface with SAP System to issue Materials to MBRs that are acceptable & released. Coordinate the review and revisions of procedures, R&D documentation and FDA regulations for inclusion in Production instructions and quality control manuals. As well as, interfacing Object Management within the MBR for Cleaning Validation, Equipment Validation and allocating the validated equipment to the Process. 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.
• Provide paperless Production recipes within the MES system. • Maintain, create and support team changes. • Provide MES 24/7 support for Production • All maintenance activities for Master Batch Records, following all appropriate procedural documentation. • Implementation and maintenance of LIMS interactions and calculations and with AQWA for deviation generation during the process. • Communicate with MES Global Novartis Team to ensure that local MES is aligned with the Global Format and structure. • Provide timely and error free documentation. • Training of Production Operators. • Coordinate with the Manufacturing team to update SOPs & TTOs • Properly control the release of proprietary documentation. • Demonstrate technical knowledge in MES systems. • Reduce the number of Master Batch Record revisions due to record flow or design • Responsible for ensuring compliance with Federal, State and local regulations and adherence to all company policies and procedures relating to GMP’s, Health, Safety & Environmental Protection. • Implement changes to Production MBRs from LD&C and synchronize with MES & ERP System. • Coordinate with Validation Engineers for Manufacturing MBRs. • Work with Manufacturing Team to implement change improvements • Maintain Material Master within the SAP System • Backup to SAP Bill of Material Maintenance. • Coordinate with IT Group MES upgrades and or changes to the system for Compliance, Training & MBR changes. • Coordinate with IT group User ID controls.
• Timely, clear, detailed, and accurate management and reporting of various EBR progress. • Ensure the required regulatory, quality, & Safety processes are considered during the creation of all EBR documents. • Effective alignment with overall launch priorities and Clinical and Commercial Operations Management

EEO Statement

The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.

Desired profile

Minimum requirements

Bachelor or similar degree Relevant GMP training English 1 -3 years experience in a regulated cGMP environment. 1 – 3 years Manufacturing Execution Systems preferred Strong aseptic manufacturing knowledge background preferred.