Principal CSV Engineer - Automation Engineering

Eli Lilly

Lebanon, IN

Pay: $67,500-$173,800/yr

Shift: Full time

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.

**Overview:**

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.

Organization and Position Overview

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 serve as a technical subject matter expert, providing automation support for one or more operating areas across the site and/or for capital projects. This role will provide technical leadership for CSV, leading and executing CSV activities for process automation systems across the site. The engineer will collaborate with cross-functional teams and provide technical expertise and direction 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. Additionally, the Engineer will serve as a key technical expert, leading projects and partnering across the Automation Engineering organization and other functional disciplines to influence and implement 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), automation engineering roles will be fluid and dynamic as we endeavor to support 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 full-scale GMP manufacturing through startup.

Responsibilities

• Lead process control validation testing, implementation, and coordination.
• Lead the development and implementation of the Automation Engineering Project Validation Plan.
• Serve as a subject matter expert 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, and QMS.
• Lead and perform risk assessments for computerized systems and develop strategies to mitigate identified risks.
• Lead the development and execution of 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.
• Lead the generation and maintenance of validation documentation, such as validation plans and summary reports.
• Develop local site procedures (e.g., SOPs, Work Instructions, etc.) related to automation systems.
• Provide technical leadership for 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 and technical guidance to personnel on CSV principles, procedures, and best practices.
• Stay informed of industry trends (e.g., CSA) and advancements in CSV and automation technologies and provide subject matter expertise regarding their application.
• Represent the Automation Department as a technical subject m