Smart Manufacturing Systems Designer

About this role

The Smart Manufacturing Systems Designer is responsible for the design, implementation, lifecycle support, and continuous improvement of Smart Manufacturing solutions at the site. The role delivers value by improving Right-First-Time performance, reducing manufacturing and review lead times, increasing digital adoption on the shop floor, and enabling data-driven decision-making across Operations, Quality, and Supply Chain. The role partners with Process Owners, Operations, Quality, Tech, Automation, Global Teams, and Smart Manufacturing leadership to understand manufacturing processes and user needs and translate them into robust, user-centered digital workflows and system solutions. Working within multidisciplinary teams, the Smart Manufacturing Systems Designer supports the full solution lifecycle, from requirements elicitation and process analysis through system design, configuration, integration, testing, validation, deployment, business-as-usual support, and continuous improvement. The scope includes electronic batch records in the MES, as well as other Smart Manufacturing systems such as low-code applications, electronic checklists and logbooks, scheduling and optimization solutions, process-data platforms, system integrations, analytics, and data visualization products. The role applies an AI-first and digital mindset, using enterprise AI-enabled tools and Smart Manufacturing learning pathways to improve productivity, business outcomes, quality of deliverables, knowledge sharing, and ways of working across the site.

Responsibilities This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following: • Lead cross-functional teams to elicit, understand, and document business and user requirements, and translate business processes into clear, actionable system workflows. Partner with global and local teams, ask the right questions, and remove roadblocks to translate shop-floor needs into actionable requirements that can be used for system design. • Act as system designer for assigned Smart Manufacturing solutions. Translate documented workflows into robust, user-centered system designs and configured solutions across relevant Smart Manufacturing platforms, ensuring alignment with local and global functional, business, and GMP requirements. • With support from Tech and Automation, design and maintain integrations among Smart Manufacturing systems and with connected enterprise and automation systems, including MES/eBR, data historians, automation/SCADA systems, SAP ERP, and other digital manufacturing tools, ensuring reliable data flows and robust execution of business rules and automated checks. • Identify applicable use cases and define testing strategies to confirm that solutions perform as intended before deployment. Define and/or create the master data needed to support testing, deployment, and accurate system configuration. • Create and maintain GMP documentation, including user requirements, design specifications, test documentation, and validation records, to support the implementation and lifecycle management of Smart Manufacturing systems. • Execute validation testing to confirm that digital solutions meet approved user, business, functional, and regulatory requirements before go-live. • Support system deployment and go-live activities, including dry-runs, end-user training, troubleshooting, and shop-floor support, to enable effective adoption and a smooth transition to new or updated systems. • Manage business-as-usual support and drive data-informed continuous improvement of assigned systems. Perform Gemba walks, proactively collect user feedback, and use operational data to identify and implement improvements that keep solutions effective and fit for purpose. • Partner with business owners and user groups to identify the data needed to support operations and decision-making and develop intuitive data visualization products that provide quick and easy access to actionable information. • Perform all job responsibilities in compliance with applicable EHS and GMP regulations, guidelines, policies, standard operating procedures, industry practices, and Industrial Excellence initiatives.

Why You? Basic Qualification We are seeking professionals with the following required skills and qualifications to help us achieve our goals: • Associate’s degree in Engineering, Computer Science, Information Systems, Industrial/Manufacturing Engineering, Automation or related technical discipline • 3+ years of experience in pharmaceutical, biopharmaceutical, or other regulated manufacturing environments, and at least one year of experience designing Smart Manufacturing or Digital Systems solutions . • Design, configure, test, deploy, support, and continuously improve Smart Manufacturing solutions in a manufacturing GMP-regulated environment. • Experience supporting project execution, testing, and validation of computerized or digital systems in a GMP-regulated environment. • Knowledge of manufacturing operations and GMP production processes, with the ability to understand shop-floor needs and their application to digital-system design. • Experience to elicit and document user and business requirements, facilitate process mapping, and translate manufacturing processes and user needs into clear, user-centered system workflows and digital solutions. • Experience to lead cross-functional discussions and communicate effectively between business and technical stakeholders, translating shopfloor and business language into actionable technical requirements and explaining technical concepts in clear business language. • Experience in technical writing and preparation of controlled documentation, including user requirements, design documentation, test and validation records, incident reports, SOPs, user guides, and training materials. • Proficiency with tools used to document and analyze requirements, processes, and workflows,

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