Labs IT Systems Deployment and Support Technical Lead

Position Brand Description

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 utilize a variety of Platforms and have the latest technology for API Manufacturing and Technology.

This is an exciting once-in-a-lifetime opportunity to help build and operate a new site. The Lilly Lebanon API Manufacturing site will be built using the latest high‑tech equipment, advanced highly integrated and automated manufacturing systems, and have a focus on minimizing the impact to our environment.

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”.

As a Lab CSV and Compliance Analyst, you will ensure the manufacturing Labs systems (MODA, Lab Vantage, NuGenesis, Empower, WInKQCL, etc) as well as computerized labs instruments are deployed with proper and right‑sized validation documents e systems and instruments are deployed, this role will evolve into monitoring, execution, and maintenance of the Laboratory IT Systems and Instruments, with an emphasis on continuous improvement, especially with regards to data integrity.

This role will harness a deep understanding of CSV and Data Integrity principles ensuring compliance with regulatory requirements, consistent application, and sustainability for local and global Technology at Lilly systems, and labs instruments used at the LP1 site. This role will collaborate with the local and global Computer System Quality Assurance team and Technology at Lilly organization to enable best practices, processes, and governance to consider new points to strengthen the Technology at Lilly CSV and Data Integrity position and align with corporate objectives and initiatives.

• 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 cross‑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 toward 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…