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.

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.

This role will work as a member of the Automation Engineering Department at Eli Lilly, Foundry. The engineer will provide automation support for one or more operating areas across site and/or for capital projects. The engineer will provide CSV support leading and executing CSV activities for process automation systems across the site, collaborating with cross‑functional teams and providing expertise in validating systems critical to the manufacture of life‑changing products at the new site.

The engineer is also responsible for ensuring that reliable and compliant control applications and systems are in place and maintained to support manufacturing operations at the Foundry. In the project delivery phase and startup phase of the project (startup expected 2025‑2028) the automation 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.

• 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 strategies to mitigate identified risks
• Develop and Execute validation protocols for computerized systems
• Ensure compliance with regulatory requirements and industry standards (GAMP, 21 CFR Part 11, Data Integrity, etc.) and corporate Lilly quality policies and procedures
• Generate and maintain validation documentation, such as validation plans and summary reports
• Develop local site procedures (SOPs, Work Instructions, etc.) related to automation systems
• Manage change control and deviation management as it pertains to CSV activities
• Collaborate with vendors to ensure that 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 (e.g., CSA) and advancements in CSV and automation technologies
• Represent the automation department during audits by…