MES Engineer

Legend Biotech is seeking a MES Engineer as part of the Manufacturing & Supply team based in Raritan, NJ. 

Role Overview

The MES Engineer will be part of Manufacturing Excellence team reporting to the Manufacturing Execution Systems Lead and will be responsible for EBR development and administration at the Raritan site to support production processing while liaising with other functions including but not limited to Tech Support, Process Improvement, Validation, Supply Chain, Operations, QA, Reg CMC, and IT. This individual will support electronic batch record (EBR) updates and system improvements, support applicable process and facility updates, and support qualification activities associated with MES (PAS-X).

Key Responsibilities

• Support eBR development, modeling, and deployment in MES
• Coordinate with other departments to gather user requirements, guage effort, and deliver robust, right first time EBR designs.
• Participate in design testing, release planning, and demos with partners.
• Serve as a Subject Matter Expert of MES for CAR-T and site initiatives requiring MES enhancements.
• Coordinate MES updates with other Supply Chain Systems (ERP, eLIMs, etc.).
• Coordinate and execute MES validation activities according to the Software Development Lifecycle (e.g. commissioning test Plans (CTP), Installation/Operational Qualification (IOQ).
• Define standardizations and update documentation (e.g. SOPs, WIs, Technical & Design Specifications, and Qualification Protocols) with alignment to Global Procedures.
• Act as a Site MES SME to support Quality Investigations, Corrections, and QMS records.
• Build the Site Readiness of MES for FDA and/or Other Regulatory Audits / Inspections.
• This individual is responsible for the training of Manufacturing Excellence on MES utilization and ensuring that Manufacturing Excellence properly assesses updates and impact.
• Key Relationships: establish key stakeholder relationships with internal and external stakeholders. Ability to interact with all levels within the organization.

Requirements

• A minimum of a Bachelor’s degree in engineering or related field or equivalent experience required. Advanced degree preferred.
• A minimum of 7 years of relevant experience is required. Demonstrated experience translating business needs to system requirements. Cell/Gene Therapy cGMP manufacturing and project planning experience preferred.
• PAS-X experience required.
• Provide technical expertise of Change Control process as well as oversight of the MES team to ensure smooth implementation of system enhancement activities.
• Accurately and reliably gauge task effort and plan work to meet project timelines
• Work closely with the development and MS&T organization to ensure translation of changes from concept to implementation, building long term implementation and support plans.
• Ability to work independently and successfully, prioritize and manage multiple tasks simultaneously, integrate cross-functional issues and balance competing priorities effectively. Must be able to manage shifting priorities to meet critical deadlines in a fast paced and dynamic, growing environment.
• Provide technical recommendation and limitations associated with MES functionality in the evaluation of potential process changes for effectiveness, value, risk, and priority.
• Drive the implementation of MES enhancements that would provide reduction in COGs, and increase throughput, capacity, and quality compliance.
• Work cross-functionally across Technical Operations and interface with IT to drive the design and implementation of new system updates for cell therapy development and manufacturing.
• When necessary, support studies related to process improvement and implementation of new manufacturing execution system technologies.
• An ability to build strong partnerships and effectively integrate with cross functional collaborators to drive projects/programs forward in a matrixed environment.
• Strong analytical, problem solving and critical thinking skills and the ability to lead as a change agent to promote flexibility, creativity, and accountability.
• Clear and succinct verbal and written communication skills.

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