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 LabVantage 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
What You Shoul
Benefits
Health insurance
Additional Information
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.
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. This is an opportunity you don't want to miss!
Eli Lilly · Lebanon IN