Labs System Analyst

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.

Lilly is entering an exciting period of growth and we are committed to delivering innovative medicines to patients around the world. Lilly is investing over $3 Billion to create a new state-of-the-art manufacturing site for Drug Substance, in Lebanon, Indiana. The brand-new facility will use a variety of Platforms and have the latest technology for API Manufacturing and Technology.

You will be part of Technology at Lilly MQ (Manufacturing and Quality), an organization that drives manufacturing operational excellence and productivity efforts through utilization of technology. Technology at Lilly MQ strives to enable the making of medicine “with safety first and quality always”.

• Leads and/or supports the laboratory with the validation of laboratory equipment and software systems including computerized analytical instrument qualification (IQ/OQ/PQ) and computerized system validation across GAMP 5 software categories.
• Supports the establishment and maintenance of the validated state of software-based computerized systems and lab instruments in use in the lab, including ownership of periodic review cycles to confirm ongoing compliance and fitness for intended use.
• Partner multi-functionally with site DI SMEs to ensure a common, systematic approach to meeting existing and new DI/CSV expectations. This includes, but is not limited to, audit trail management, workstation security, and connecting stand-alone equipment.
• Supports site deployment and upgrade of laboratory IT systems such as MODA, Empower, NuGenesis, and Lab Vantage with any CSV needs
• Partners and establishes relationships with Global Quality Laboratory Network, Global and Site IT team members, Computer System Quality Assurance (CSQA), site Quality Assurance, and external vendor/supplier organizations.
• Provides oversight and supports continuous improvement of systems/instruments as they relate to the labs
• Applies knowledge of quality principles, cGMP, and laboratory systems towards the development and execution of local procedures, training courses, and practices
• Manages and supports both internal or external audit and inspection activities for the laboratory.
• Performs change control, investigations, root cause analysis, and activity planning
• Performs System Administration for E3B system
• Coordinate the technical evaluation with site Tech@Lilly subject matter experts (SMEs) of new and existing systems from a Data Integrity and CSV perspective for both labs systems and computerized labs instruments.
• Provide CSV consulting and assist with articulation of CSV needs to the CSV third party service provider(s).
• Lead and participate in DI/CSV related deviations and CAPAs in the scope of LP1 labs area.
• Ensures Lilly information assets are protected from malicious content and access to information is restricted to authorized personnel only.
• Leads team of contract resources in the management and support of labs instruments

• Bachelor of Science degree in IT, Engineering, Computer Science, or related field
• 5+ years of relevant work…