Principal Engineer - Systems

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.

Organization and Role Overview:

Lilly is entering an exciting and outstanding period of growth. The Manufacturing and Quality (MQ) Tech at Lilly organization is engaged in an exciting phase of transformation as we drive our Digital Plant vision across Lilly manufacturing at the same time supporting unprecedented growth in Lilly’s manufacturing operation across the world.

This position develops, deploys, and supports laboratory and/or manufacturing systems to meet business and regulatory needs. This position requires business area knowledge and computer expertise to provide in-depth support for new and existing laboratory and/or manufacturing applications, systems, and computerized equipment. This position will be responsible for the maintenance, updates and troubleshooting of Lab Systems (ie LIMS, Nugenesis, SoftMax Pro, LabVantage) related items. Additionally, this position will assist with site projects such as system updates and/or enhancements. This individual will solve computerized system issues, analyze information, implement new systems, and maintain and enhance existing solutions in accordance with corporate standards and guidelines. This role will collaborate with global IDS teams to meet goals for both current and anticipated future needs for new and existing technologies, practices and initiatives.

Responsibilities:

• Create, modify, and enhance applications and systems to satisfy business information demands. Facilitate changes by delivering feedback from customers to application teams and communicate any changes applied ensuring operational procedures stay current and relevant.
• Assure adherence of applicable regulatory (i.e. cGXP, CFR, etc.) practices during execution of all work activities. Participate in audits, inspections, and associated readiness activities.
• Support and participate in LIMS related projects for upgrades and enhancements including change control impact assessments.
• Be responsible for and participate in the installation, configuration, and validation of LIMS applications. Develop and implement project plans, ensuring timely and quality delivery of solutions. Manage system customizations, scripts, and user interface enhancements.
• Proven ability to translate and lead complex lab/scientific requirements into LIMS capabilities.
• Design and implement integrations between LIMS, SAP and third-party systems (ie Empower, etc), including instruments and databases.
• Responsible for daily support of end users, and provide end user training
• Perform the pre-validation assessment of all computerized laboratory and/or manufacturing systems, ensuring that all validation requirements have been met prior to system testing.
• Enable data-driven decision making in pharmaceutical Quality Control and Manufacturing by developing and deploying interactive, easy-to-use dashboards and reports that support self-service analytics, ensure secure and compliant access to critical data, and provide real-time insights to enhance process efficiency, product quality, and regulatory compliance.
• Identify, recommend, and implement automated solutions to address QC laboratory or manufacturing operations. Execute with precision, speed, and simplicity, ensuring compliance with Computer Systems Validation policies, standards, procedures, and practices. Train and assist business users in proper use of applications and computerized systems.
• Foster professional and inclusive behavior, invite new ideas and differing perspectives among team members, assuring an on-going positive relationship with the customers and other members of the IDS organization. Inspire and recognize teamwork.
• Serve as a liaison between local and corporate systems groups, cross-functional or cross-site teams, as requested, interfacing with system owners, IDS, QC, QA, Manufacturing, AEG, vendors, and other relevant functional areas. Build enterprise and cross-site connections to ensure integration and results.
• Develop and implement a change management strategy in partnership with cross-functional initiative teams.
• Identify, analyze, prepare risk mitigation tactics, and manage anticipated resistance.
• Consult and coach project teams and support communication and training efforts.
• Integrate change management activities into project