Principal/Sr. Principal QC Laboratory Informatics Specialist

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.Lilly is currently constructing an advanced manufacturing facility for production of API (Active Pharmaceutical Ingredient) molecules located in Lebanon, IN. This facility is Lilly’s largest investment in manufacturing capacity and is intended to provide APIs for current and future products, including new modalities. This is a unique opportunity to be a part of the startup team for a greenfield manufacturing site, and the successful candidate will help to build the processes and facility to enable a successful startup into GMP manufacturing operations.Position Description:The QC Laboratory Informatics Role is responsible for monitoring laboratory performance to ensure that the QC laboratory maintains a state of control regarding the generation and reporting of analytical data. Responsibilities will initially involve interacting with global and local IT support functions to populate master data, configure systems, and assist with installing and qualifying laboratory IT systems such as LIMS/LES (LabVantage), MODA, WinKQCL, ELN (NuGenesis), CDS (Empower), and other lab systems. The role will evolve into monitoring, execution, maintenance, and continuous improvement of the Laboratory IT Systems for the QC lab with an emphasis on continuous improvement, focused on data integrity. This role will serve as a representative for laboratory IT systems and will be responsible for mentoring and educating peers on the use of lab systems, supporting audits, and oversight for management reviews, laboratory metrics, laboratory equipment, and laboratory documentation.Key Objectives:Performs and/or supports the laboratory with the validation of laboratory equipment and software systems.Supports the establishment and maintenance of the validated state of software-based computerized systems in use in the lab.Ensures data integrity by design within the QC laboratory.Assists with Site Deployment and upgrade of QC Laboratory IT Systems.Partners and builds relationships with Global Quality Laboratory Network, Global and Site IT team members.Acts as a contact SME for QC Laboratory IT Systems.Collects data and authors management review documents for the laboratory quality system.Supports continuous improvement of quality systems as they relate to the QC lab.Applies knowledge of quality principles, cGMP, and laboratory systems towards the development and execution of local procedures, training courses, and practices.Assists in improvement of quality systems by creating or revising worksheets, developing or updating laboratory execution system documentation, updating laboratory methods, and maintaining other lab documentation systems.Supports audit and inspection activities for the laboratory.Implements and complies with corporate, site, and laboratory safety standards.Develops training materials for laboratory informatics systems.Basic Requirements:Bachelor’s degree in Computer Science, Information Systems, Chemistry, Microbiology, Biology, or other relevant field3+ Years in GMP QC Laboratory IT Systems Experience (Installation and Qualification of Laboratory IT Systems, Population of Master Data, and Configuration of systems).Additional Skills/Preferences:Deep understanding of compliance requirements and regulatory expectationsDemonstrated accuracy and proficiency in analytical skills.Proficiency with computer systems including Microsoft Office products, LIMS, Laboratory Execution Systems, chromatography systems, electronic laboratory notebook systems including implementation of systems.Ability to work in a lab environment including wearing appropriate PPE and other safety related equipment or considerations.Excellent written and oral communication skillsPrevious LEAN experience: ability to drive continuous improvement.Experience operating or implementing Lab IT systems including LIMS and Automated Lab Execution systems.Previous experience with cross-function leadership utilizing problem-solving and decision-making skills.Additional Information:Ability to work 8-hour days, Monday through Friday.Available Off Shift to respond to operational issues.Limited travel may be required during the facility project phase.

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