Manager, Manufacturing Systems

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The Manager, Manufacturing Systems is an integral part of the Internal Manufacturing team. This role is the end-user subject matter expert for the Manufacturing Execution System (MES) and Real-Time Modeling System (RTMS). The SME will provide input to the conceptual design, detailed design, specification, user acceptance testing, implementation, qualification, trouble‑shooting, and continuous improvement of these manufacturing systems to maximize productivity. This position is onsite in Norton, MA.

• End-user Subject Matter Expert (SME) for the Manufacturing Execution System (MES), Real-Time Modeling System (RTMS), and other IT capability systems (such as SAP, LIMS, Infor) that support Norton manufacturing operations, with an initial focus on implementing these systems for the buildout of Norton’s new commercial drug substance manufacturing train
• Develops user requirements, functional requirements, and/or technical specifications for deployment of new systems in close collaboration with other stakeholders
• Identifies and Ensures MES solutions are fit for purpose for manufacturing operations.
• Supports system configuration, testing and qualification with a focus on manufacturing usability and cGMP compliance.
• Provides routine on the floor support for MES during start-up, Engineering runs, validation and routine production.
• Supports batch record execution and production E  workflow issues in collaboration with Quality Assurance.
• Identifies opportunities to enhance manufacturing performance through improved MES functionality, automation and data integrity.
• Maximizes capacity utilization through finite scheduling and resource loading.
• Assists in creating and revising documentation and qualifying systems in alignment with policies, procedures, and regulatory requirements (e.g., 21 CFR Part 11, etc.)
• Follows applicable change control and change management procedures to plan, assess, and implement changes
• Executes and/or manage execution of protocols, test scripts, and change plans, as applicable
• Remains current on new technologies, trends, and best practices that can bring innovation to manufacturing execution and information systems
• May support and participate in audit and inspection activities, including inspection readiness
• Provide on-going and on-the-floor manufacturing operations support for MES, RTMS, and other systems as applicable
• Supports the multiyear strategic planning process for MES systems to standardize execution of batch records, reduce human error, shorten batch release, give real time data while embedding compliance directly into operations.

• B.S. in scientific or engineering field preferred
• Minimum of 5 years overall experience, including at least 3 years’ experience working on MES/RTMS systems in the Life Sciences industry
• Deployment experience with MES and RMTS solutions preferred
• Previous experience in commercial cGMP manufacturing operations is desired
• Experience developing user requirements, functional specification documents and test scripts for MES/RTMS projects
• Demonstrate understanding of Networking & System Security Fundamentals and knowledge of S88, S95, OPC, Data Historian, System Interfaces, Distributed Control Systems, etc.
• Excellent communication, interpersonal, and organizational skills with the ability to manage priorities in a fast‑paced, dynamic environment