CSV Engineer - Automation Engineering

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life‑changing medicines, strengthen how health is understood and managed, and support the communities we serve.

This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

We unify caring with discovery to make life better for people worldwide. We are a global healthcare leader headquartered in Indianapolis, Indiana, dedicated to discovering and delivering life‑changing medicines, improving the understanding and management of disease, and giving back to communities through philanthropy and volunteerism. We put people first and strive to bring our best effort to everything we do.

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 will combine research and manufacturing in a single location, enabling us to develop innovative solutions that optimize manufacturing processes, increase capacity for clinical‑trial medicines, and reduce costs and environmental impact.

This role will serve as a member of the Automation Engineering Department at the Foundry. The engineer will provide automation support for one or more operating areas across site and/or for capital projects. Responsibilities include CSV support, validating systems critical to the manufacture of life‑changing products, ensuring compliant control applications, and influencing the technical agenda across the organization.

In the project delivery and startup phases (expected 2025‑2028), automation engineering will be fluid and dynamic as we build the new organization, develop and implement the necessary systems and business processes to support GMP operations, and cultivate a culture of collaboration, creativity, and resilience.

• Process control validation testing, implementation, and coordination
• Develop and implement the Automation Engineering Project Validation Plan
• Provide subject‑matter expertise for computer system validation and data integrity for automation systems across the site, including Process Automation Systems (DCS, SCADA, BMS, MES, Historian), Building Management System, Vendor‑Packaged Equipment, Data Historian, Automated Storage and Retrieval System, QMS
• Perform risk assessments for computerized systems and develop mitigation strategies
• Develop and execute validation protocols for computerized systems
• Ensure compliance with regulatory requirements and industry standards (GAMP, 21 CFR Part 11, Data Integrity) and corporate Lilly quality policies
• Generate and maintain validation documentation (plans and summary reports)
• Develop local site procedures (SOPs, Work Instructions, etc.) related to automation systems
• Manage change control and deviation management for CSV activities
• Collaborate with vendors to ensure third‑party systems and software meet validation requirements; conduct vendor audits as needed
• Provide training to personnel on CSV principles, procedures and best practices
• Stay informed of industry trends and advancements in CSV and automation technologies
• Represent the automation department during audits by regulatory agencies as assigned
• Act as functional owner for the Electronic testing system (Kneat, ALM, Valgenesis) managing CSV documents related to automation systems

• Review and oversee Design documentation, including Functional Requirements, Design Specifications, DCS Application Software, and Test Specifications
• Lead or participate in design reviews and Automation application software reviews to ensure compliance and standardization
• Provide periodic status updates to Project Management
• Devise CSV and quality strategies for control systems in…