Eli Lilly and Company
Engineer - Automation Engineering – Control System Data Analyst
Eli Lilly and Company, Lebanon, Indiana, United States, 46052
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Lilly recently announced a $4.5B investment to create the Lilly Medicine Foundry, a new center for advanced manufacturing and drug development. The Foundry integrates research and manufacturing in a single location, enabling innovative solutions to optimize manufacturing processes while increasing capacity for clinical trial medicines and reducing costs and environmental impact.
Job Title: Engineer - Automation Engineering – Control System Data Analyst
Overview The Engineer-Automation Engineering – Control System Data Analyst is a technical individual contributor for the Foundry Automation Engineering Team. In this role you will provide data engineering and analytics solutions, collaborate with Automation Engineers and System Administrators to maintain, configure, and troubleshoot automation control systems and interfaces, support daily operations, and help implement the process control technical agenda across functional disciplines.
Responsibilities Key Objectives/Deliverables
Provide/Support input to design decisions regarding development and integration of Automation Data Analytics systems and overall Foundry Data Analytics initiatives.
Lead development and implementation of analytics strategies and tools for metrics, visualization and dashboards across multiple platforms and functional areas.
Interface with Automation teams and user groups to develop requirements and designs that meet business needs.
Promote use of data analytics to support site business goals, including training on analytics tools and techniques.
Support qualification and delivery of Automation Servers, Network and Infrastructure and applications.
Support the Process Control Validation Plan, CSV, Quality Documents, SOPs, and audit readiness.
Audit Readiness
Support execution and creation, review, and approval of documentation for compliance activities such as periodic reviews and application recovery process.
Support key business processes such as audit, investigation and CAPA.
Monitor, administer and optimize Automation Quality deliverables (Incidents, Actions, Deviations, Resolutions).
Act as system owner for the electronic testing system (Kneat, ALM, Valgenesis) managing CSV documents for automation systems.
Administer relational databases using Microsoft SQL Server Management Studio; basic to intermediate competency with SQL, PowerBI and software development.
Experience with data flows and interfaces associated with instrumentation and system integration protocols is a plus.
Provide support for computer system data architecture and data integrity for automation systems across the site, including ServiceNow, Veeva, DCS, SCADA, BMS, MES, Historian, and LMS.
Ensure compliance with regulatory requirements and industry standards (GAMP, 21 CFR Part 11, Data Integrity) and Lilly quality policies.
Maintain validation documentation, such as validation plans and summary reports.
Provide training on CSV principles, procedures and best practices.
Operational Excellence
Collaborate with Site Area leads and System Integrator to ensure Data Historization and System architecture are considered in design.
Provide periodic status updates to Automation Engineering Management.
Work with Engineering, Operations and cross‑functional groups to troubleshoot issues, coordinate changes with data historian systems, and perform routine system maintenance.
Interface cross‑functional systems such as Historians, QMS, LMS, CMDB, CMMS, ITSM.
Develop SOPs, work instructions and other job aids for design, operation, organization, maintenance and optimization of the Foundry Configuration Management Database (ServiceNow).
Identify, track and report key performance indicators.
Organize and manage a knowledge base for troubleshooting applications following templates regarding problem, traceability, accountability, and resolution.
Support and implement CSV and quality strategies for control systems in collaboration with Site Quality.
Promote automation and analytics to improve productivity, operational efficiency and compliance.
Develop a professional network of corporate contacts for leveraging expertise.
Organizational Capability
Set and reinforce standards for rigor in automation work products in coordination with automation and compliance consultants.
Actively participate on management sub‑teams as a member of the engineering team.
Basic Requirements
Minimum B.S. in IT, Engineering or related discipline and 3+ years’ experience in Computerized System Validation and Data Analytics, preferably in pharmaceutical manufacturing.
Additional Preferences
3+ years working experience in Biopharma engineering, operations or manufacturing.
Knowledge of GMP regulatory requirements, computer system validation, execution and data integrity.
Experience in design, development, commissioning and qualification of highly automated greenfield manufacturing sites utilizing SCADA, DCS, MES, LIMS, Power BI, QMS and Site Historian systems.
Experience in design and development of data analysis and data contextualization to support site functions and metrics.
Ability to work in a matrix organization and demonstrate key interpersonal skills.
Ability to ensure appropriate technical depth and rigor with departmental technical deliverables.
Ability to make independent decisions and network with others as appropriate.
Ability to work with key network and enterprise partners to adopt new data analytics and enterprise integration technologies.
Ability to influence peers and business partners.
Other Information
Initial location at Lilly Technology Center, Indianapolis.
Permanent location at the new Lilly Medicines Foundry in Lebanon, Indiana.
Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated salary range is $66,000 - $171,600.
Full‑time employees are also eligible for a company bonus based on performance, and to a comprehensive benefit program that includes 401(k), pension, vacation, medical, dental, vision, prescription drug, flexible benefits, life insurance, and various leave and wellness benefits.
For accommodation requests, please complete the accommodation request form at https://careers.lilly.com/us/en/workplace-accommodation for further assistance.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
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Job Title: Engineer - Automation Engineering – Control System Data Analyst
Overview The Engineer-Automation Engineering – Control System Data Analyst is a technical individual contributor for the Foundry Automation Engineering Team. In this role you will provide data engineering and analytics solutions, collaborate with Automation Engineers and System Administrators to maintain, configure, and troubleshoot automation control systems and interfaces, support daily operations, and help implement the process control technical agenda across functional disciplines.
Responsibilities Key Objectives/Deliverables
Provide/Support input to design decisions regarding development and integration of Automation Data Analytics systems and overall Foundry Data Analytics initiatives.
Lead development and implementation of analytics strategies and tools for metrics, visualization and dashboards across multiple platforms and functional areas.
Interface with Automation teams and user groups to develop requirements and designs that meet business needs.
Promote use of data analytics to support site business goals, including training on analytics tools and techniques.
Support qualification and delivery of Automation Servers, Network and Infrastructure and applications.
Support the Process Control Validation Plan, CSV, Quality Documents, SOPs, and audit readiness.
Audit Readiness
Support execution and creation, review, and approval of documentation for compliance activities such as periodic reviews and application recovery process.
Support key business processes such as audit, investigation and CAPA.
Monitor, administer and optimize Automation Quality deliverables (Incidents, Actions, Deviations, Resolutions).
Act as system owner for the electronic testing system (Kneat, ALM, Valgenesis) managing CSV documents for automation systems.
Administer relational databases using Microsoft SQL Server Management Studio; basic to intermediate competency with SQL, PowerBI and software development.
Experience with data flows and interfaces associated with instrumentation and system integration protocols is a plus.
Provide support for computer system data architecture and data integrity for automation systems across the site, including ServiceNow, Veeva, DCS, SCADA, BMS, MES, Historian, and LMS.
Ensure compliance with regulatory requirements and industry standards (GAMP, 21 CFR Part 11, Data Integrity) and Lilly quality policies.
Maintain validation documentation, such as validation plans and summary reports.
Provide training on CSV principles, procedures and best practices.
Operational Excellence
Collaborate with Site Area leads and System Integrator to ensure Data Historization and System architecture are considered in design.
Provide periodic status updates to Automation Engineering Management.
Work with Engineering, Operations and cross‑functional groups to troubleshoot issues, coordinate changes with data historian systems, and perform routine system maintenance.
Interface cross‑functional systems such as Historians, QMS, LMS, CMDB, CMMS, ITSM.
Develop SOPs, work instructions and other job aids for design, operation, organization, maintenance and optimization of the Foundry Configuration Management Database (ServiceNow).
Identify, track and report key performance indicators.
Organize and manage a knowledge base for troubleshooting applications following templates regarding problem, traceability, accountability, and resolution.
Support and implement CSV and quality strategies for control systems in collaboration with Site Quality.
Promote automation and analytics to improve productivity, operational efficiency and compliance.
Develop a professional network of corporate contacts for leveraging expertise.
Organizational Capability
Set and reinforce standards for rigor in automation work products in coordination with automation and compliance consultants.
Actively participate on management sub‑teams as a member of the engineering team.
Basic Requirements
Minimum B.S. in IT, Engineering or related discipline and 3+ years’ experience in Computerized System Validation and Data Analytics, preferably in pharmaceutical manufacturing.
Additional Preferences
3+ years working experience in Biopharma engineering, operations or manufacturing.
Knowledge of GMP regulatory requirements, computer system validation, execution and data integrity.
Experience in design, development, commissioning and qualification of highly automated greenfield manufacturing sites utilizing SCADA, DCS, MES, LIMS, Power BI, QMS and Site Historian systems.
Experience in design and development of data analysis and data contextualization to support site functions and metrics.
Ability to work in a matrix organization and demonstrate key interpersonal skills.
Ability to ensure appropriate technical depth and rigor with departmental technical deliverables.
Ability to make independent decisions and network with others as appropriate.
Ability to work with key network and enterprise partners to adopt new data analytics and enterprise integration technologies.
Ability to influence peers and business partners.
Other Information
Initial location at Lilly Technology Center, Indianapolis.
Permanent location at the new Lilly Medicines Foundry in Lebanon, Indiana.
Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated salary range is $66,000 - $171,600.
Full‑time employees are also eligible for a company bonus based on performance, and to a comprehensive benefit program that includes 401(k), pension, vacation, medical, dental, vision, prescription drug, flexible benefits, life insurance, and various leave and wellness benefits.
For accommodation requests, please complete the accommodation request form at https://careers.lilly.com/us/en/workplace-accommodation for further assistance.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
#J-18808-Ljbffr