Engineer - Automation Engineering – Control System Data Analyst

Eli Lilly and Company • Lebanon, IN

23h • $66,000 - $171,600

About The Position

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. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. Lilly recently announced a $4.5 billion investment to create the Lilly Medicine Foundry, a new center for advanced manufacturing and drug development. The first-ever facility of its kind, combining research and manufacturing in a single location, the Medicine Foundry will allow Lilly to further develop innovative solutions to optimize manufacturing processes and increase capacity for clinical trial medicines, while also reducing costs and environmental impact. The Engineer-Automation Engineering – Control System Data Analyst, is a technical individual contributor for the Foundry Automation Engineering Team. This individual will be responsible for providing data engineering and analytics solutions for The Foundry Automation Engineering organization. This role in collaboration with the Automation Engineers and System Administrators will maintain, configure, and troubleshoot the different Automation Control Systems and interfaces supporting the data historization and analytics for the Foundry. This role will be involved in the support of the daily operations of the Foundry and will contribute to the operations, productivity and development of reliable and compliant control applications and systems used in the manufacturing at Foundry. Additionally, the Engineer partners to influence and implement within the process control organization and across functional disciplines to support the process control technical agenda, business plan priorities, and compliance objectives. In the project delivery phase and startup phase of the project (startup expected 2025 to 2028), engineering roles will be fluid and dynamic as we endeavor to support the project delivery, build a new organization, develop and implement the necessary systems and business processes required to support GMP operations, and build the site culture. This will require significant collaboration, creativity and resilience as the site grows to a full scale GMP manufacturing through start up.

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.

Nice To Haves

• 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 (DeltaV, Rockwell, Syncade, LabVantage, Veeva, Analysis tools, Aveva PI).
• Experience in design and development of data analysis and data contextualization to support site functions and metrics.
• Ability to work in a matrix organization within the department and cross functionally and demonstrate key interpersonal skills.
• Ability to ensure appropriate technical depth and rigor with departmental technical deliverables.
• Ability to make decisions independently and to network with others as appropriate.
• Ability to work with key network and enterprise partners in utilizing new technology in data analytics and enterprise integration
• Ability to influence peers and business partners
• Basic to intermediate competency with SQL, PowerBI and software development applications
• Experience with data flows and interfaces associated with instrumentation and system integration protocols a plus.

Responsibilities

• 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 based on complex user requirements across multiple platforms and functional areas
• Interface with the Automation teams and the user groups to develop requirements and designs to meet the business needs.
• Promote the use of data analytics to support achievement of site business goals including promoting awareness and training on data analytics tools and techniques across the Automation Engineering organization
• Support qualification and delivery of Automation Servers, Network and Infrastructure and applications
• Support the Process Control Validation Plan, CSV, Quality Documents, SOP’s and Audit Readiness
• Support the execution and creation, review, and approval of documentation associated with procedure-driven compliance activities such as periodic reviews and application recovery process as part of business continuity initiatives
• Support key business processes such as audit, investigation and CAPA
• Monitor, Administer and optimize Automation Quality deliverables (Incidents, Actions, Deviations, Resolutions)
• Act as a system owner for the electronic testing system (Kneat, ALM, Valgenesis) managing CSV document relating to automation systems
• Working experience administering relational databases with RDBMS tools such as Microsoft SQL Server Management Studio.
• Provide support for computer system data architecture and data integrity for automation systems across the site including:
• Foundry Configuration Management Database (ServiceNow), QMS (Veeva)
• Process Automation Systems (DCS, SCADA, BMS, MES, Historian)
• Data Historian (DeltaV Historian, FT Historian, Metasys Historian, Aveva PI, Ignition, WIN911)
• LMS (SuccessFactors)
• Ensure compliance with regulatory requirements and industry standards (GAMP, 21 CFR Part 11, Data Integrity) and corporate Lilly quality policies and procedures
• Maintain validation documentation, such as validation plans and summary reports
• Provide training to personnel on CSV principles, procedures and best practices
• Technically collaborate with Site Area leads and System Integrator including Functional Requirements, Design Specifications, DCS Application Software, Test Specifications to ensure Data Historization and System architecture is considered.
• Provide periodic status updates to Automation Engineering Management
• Work with Engineering, Operations and many cross functional groups to trouble shoot issues, coordinate changes with data historian systems in line with site change control procedures and site standards, responding to system events and performing routine system maintenance checks
• Lead the interfacing of cross functional systems such as Historians, QMS, LMS, CMDB, CMMS, ITSM
• Develop standard operating procedures, work instructions and other job aids to ensure the appropriate level of documentation is in place to design, operate, organize, maintain and optimize the Foundry Configuration Management Database (ServiceNow).
• Identify, track, and report key indicators of functional performance
• Organize, document and manage 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 organization
• Promote the use of automation and analytics to improve productivity, operational efficiency and compliance
• Develop a ‘network’ of corporate contacts and leveraging corporate expertise when needed
• In coordination with automation and compliance consultants, set and reinforce standards for appropriate rigor in automation work products.
• Be a fully active member of the engineering team in running the plant, including participation on management sub-teams.

Benefits

• 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).

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees