Labs IT Systems Deployment and Support Technical Lead

Position Overview

Join Lilly’s new Lebanon, Indiana API Manufacturing site to build and operate a world‑class facility. In this role, you will support the launch and ongoing compliance of laboratory information systems and instruments.

• Validate and deploy manufacturing Laboratory Systems (MODA, Lab Vantage, NuGenesis, Empower, WinKQCL, etc.) and computerized instruments with proper CSV documentation at LP1.
• Monitor, execute, and maintain Laboratory IT Systems and instruments, focusing on continuous improvement and data integrity.
• Collaborate with site DI SMEs, global CSQA, IT, and vendors to strengthen CSV and Data Integrity practices.
• Perform system administration for the E3B system and coordinate technical evaluation of new/renewed labs equipment from a data integrity perspective.
• Manage internal and external audit and inspection activities, including change control, investigations, root‑cause analysis, and CAPA development.
• Lead and coordinate DI/CSV related deviations and CAPAs within the LP1 labs scope.
• Support training, documentation, and continuous improvement initiatives for labs systems.

• Lead and support validation of laboratory equipment and software systems, including IQ/OQ/PQ and GAMP5 compliance.
• Maintain validated state of software‑based computerized systems and instruments, performing periodic reviews.
• Partner cross‑functionally to ensure systematic approach to DI/CSV expectations, including audit trail management and workstation security.
• Establish relationships with Global Quality Laboratory Network, Global and Site IT teams, CSQA, QA, and external vendors.
• Apply knowledge of quality principles, cGMP, and laboratory systems to develop local procedures, training, and best practices.
• Analyze, anticipate, and resolve complex technical, operational, and business issues proactively.
• Adapt to a fast‑paced environment and prioritize issues effectively.

• Strong Data Integrity knowledge and experience implementing solutions for computerized systems and instruments.
• Proficiency with CSV and ability to right‑size validation based on risk.
• Solid knowledge of Computer System Validation, GAMP, and GMP processes.
• Excellent communication, interpersonal, analytical, and problem‑solving skills.
• Experience managing audit, CAPA, change control, and investigations.
• Ability to prioritize, scale, and support multiple tasks in a regulated environment.

• Bachelor’s degree in IT, Engineering, Computer Science, or related field.
• 5+ years of CSV work experience in a regulated (GMP) industry with a strong understanding of quality processes in IT.
• Authorization to work full‑time in the United States.

Monday through Friday, on‑site in Lebanon, IN. Occasional extended or off‑hour work may be required, and travel to other U.S. or global Lilly sites might be necessary.

Lilly is a proud Equal‑Employment‑Opportunity employer and does not discriminate on the basis of any legally protected status. Lilly welcomes individuals with disabilities and will provide reasonable accommodation throughout the application process. If accommodation is required, please submit a request form through our careers portal.