Computer System Validation Manager Jobs in Wisconsin

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Position:

The Senior Automation Engineer - Central Automation serves as the site Subject Matter Expert (SME) for the integration of automated manufacturing processes, data exchange, and centralized management of production information across the LKC automation architecture. This role is distinct from Process Engineering, which owns the design, programming, and troubleshooting of PLC, SCADA, and HMI applications at the equipment/process level. The Central Automation SME instead owns the layer that connects and orchestrates those systems: the flow of recipes, parameters, cycle and batch data, material and process identification, and material handling automation across the site network, ensuring that physical processes and data exchange occur in a consistent, automated, and compliant manner from the plant floor up through site and enterprise systems.

This role requires deep technical understanding of system integration architectures, data historian administration, MES/recipe management, and material handling/identification systems, combined with the ability to troubleshoot cross-system data flow issues that span multiple platforms and vendors.

Responsibilities:

Key Objectives/Deliverables:

Process & Systems Integration

• Own the integration architecture connecting shop-floor control systems (PLC/SCADA/HMI, owned by Process Engineering) with site-level automation and business systems (MES, historian, LIMS, QMS, ERP interfaces)

• Design, configure, and maintain data exchange interfaces (OPC UA, MQTT, web services, database interfaces) between control systems and central platforms

• Serve as the technical owner for recipe management, parameter master data, and centralized batch/cycle report generation and distribution

• Ensure consistency and integrity of process and material data as it moves across integration layers

Data Historian & Data Management

• Administer and optimize the site data historian (e.g., OSI PI or equivalent), including tag architecture, data contextualization, and retention strategy

• Support data analytics and reporting initiatives by ensuring clean, structured, and accessible process data

• Partner with Data Analytics/IT teams to enable dashboards, trending, and KPI reporting from integrated data sources

• Maintain data integrity compliance (21 CFR Part 11, ALCOA+) across all integrated data flows

Material Handling & Identification Systems Integration

• Serve as SME for the integration of automated material handling systems (AS/RS, AGVs/AMRs, conveyors, automated warehouse/logistics systems) with production and business systems

• Own the integration of process and material identification systems (barcode, RFID, vision-based ID) into the site's data and tracking architecture

• Ensure seamless, automated data exchange between material movement/storage systems and MES/ERP for traceability and genealogy

Technical Leadership & Compliance

• Act as site SME for Central Automation integration topics, providing technical guidance to Process Engineering, Manufacturing, and IT/OT teams

• Support investigations, root cause analysis, and change controls related to system integration and data flow issues

• Develop and maintain technical documentation (functional specifications, data flow diagrams, interface control documents) for integrated systems

• Support computer system validation (CSV) activities for integration platforms and data historian systems

• Represent Central Automation integration topics during regulatory inspections and audits, as needed

• Stay current on integration technologies and industry best practices (Industry 4.0, IIoT, MES/MOM platforms) and recommend improvements

Basic Requirements:

• Minimum B.S. in Engineering, Computer Science, Information Technology, or related field

• Minimum 5 years of experience in industrial automation, systems integration, or manufacturing IT/OT, preferably in a cGMP environment

• Demonstrated experience with data historian systems, MES, and system-to-system data integration

• Experience with material handling/identification systems integration (AS/RS, AGV, barcode/RFID) is a plus

• Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.

Additional Preferences:

• Technical expertise in data historian platforms (e.g., OSI PI), MES/MOM platforms (e.g., Syncade, POMSnet), and integration protocols (OPC UA, MQTT)

• Working knowledge of PLC/SCADA/HMI systems sufficient to interface effectively with Process Engineering (not required to program or troubleshoot at the control level)

• Experience with recipe/parameter management systems in a batch manufacturing environment

• Knowledge of data integrity and CSV requirements (GAMP, 21 CFR Part 11)

• Experience with warehouse/logistics automation systems in a regulated manufacturing environment

• Strong analytical and problem-solving skills across multi-vendor, multi-platform environments

• Ability to translate business/operational needs into technical integration solutions

• Strong written and verbal communication skills across technical and non-technical audiences

Other Information:

• Location: Lilly Kenosha County (LKC), Pleasant Prairie, Wisconsin

• Standard business hours (days, M-F) with occasional off-hour support for integration testing, upgrades, or shutdown activities

• Minimal travel required

• Tasks require entering manufacturing areas which require wearing appropriate PPE

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

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Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women's Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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