QC Lab Systems 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. Tech at Lilly QC Lab Systems Analyst | Lilly Kenosha Position Summary Lilly is entering an exciting period of growth, and we are committed to delivering innovative medicines to patients around the world. This is an exciting once-in-a-lifetime opportunity to work in a state-of-the-art manufacturing site in Pleasant Prairie, Wisconsin. The facility will utilize the latest technology to increase the company's manufacturing capacity in parenteral (injectable) medications, device assembly and packaging operations. The Lilly Kenosha site will leverage use of high-tech equipment, advanced highly integrated and automated manufacturing systems, and have a focus on minimizing the impact to our environment. As QC Lab Systems Analyst, your main function is to deliver, integrate, and support the computerized systems used in the Lilly Kenosha Quality Control laboratories, including the Laboratory Information Management System (LIMS), Chromatography Data System (CDS), and laboratory instrument integrations. You will partner closely with the QC laboratories, Quality Assurance, and global Tech@Lilly teams to ensure lab systems are reliable, compliant, and enable right-first-time testing and timely batch release. At the P3 level, you will act as technical lead for QC lab systems workstreams, own solution design and integration decisions for your area, and mentor team members. Key Responsibilities 1. QC Lab Systems Delivery: • Design, configure, implement, enhance, and maintain QC laboratory systems, including LIMS (e.g., LabVantage), CDS (e.g., Waters Empower), and laboratory instrument data systems. • Translate QC laboratory requirements (sample management, test methods, specifications, stability, environmental monitoring, and release workflows) into system designs and master data configurations. • Lead integration of laboratory instruments and lab systems with LIMS, CDS, and enterprise systems (e.g., SAP S/4HANA, MES) using site edge connectivity and global integration patterns. • Stay up to date with emerging laboratory digital technologies (paperless lab, lab automation, data analytics) and recommend their application at the site. 2. System Operations and Support: • As a Process Team member, own day-to-day operations of QC lab systems, ensuring availability and performance to support testing and batch release. • Lead incident, problem, and change management for lab systems, including root cause analysis for complex or recurring issues and corrective and preventive actions. • Manage system lifecycle activities, including upgrades, patching, periodic reviews, user access management, and backup, restore, and disaster recovery testing. 3. Compliance and Data Integrity: • Ensure QC lab systems comply with 21 CFR Part 11, EU Annex 11, GMP requirements, data integrity (ALCOA+) principles, Lilly policy and procedures, and local procedures. • Own computer system validation deliverables for lab systems using a risk-based approach consistent with GAMP 5 and Lilly computer system validation standards. • Ensure audit trail review and electronic record and signature controls are designed, documented, and executed. • Serve as QC lab systems subject matter expert during internal and external inspections and ensure timely execution of findings management. 4. Collaboration and Continuous Improvement: • Collaborate with QC Chemistry, QC Microbiology, Quality Assurance, Engineering, global Tech@Lilly lab systems teams, and vendors to drive continuous improvement in laboratory operations. • Effectively influence the business to drive value and implement the appropriate digital solutions. 5. Technical Leadership: • Provide technical mentoring and development for lab systems team members. • Represent the site in network and global lab systems forums, benchmarking solutions internal and external to Lilly. Basic Qualifications • Bachelor's degree in Computer Science, Engineering, Chemistry, Life Sciences, or a related field such as Chemical Engineer, Laboratory Sciences or Petroleum Engineering. • Minimum of 5 years of experience implementing or supporting QC laboratory systems (LIMS, CDS, or instrument integration) in a GMP-regulated industry. • Hands-on experience with at least one commercial LIMS or CDS (e.g., LabVantage, LabWare, Waters Empower, or Thermo Chromeleon). • In-depth understanding of 21 CFR Part 11, EU Annex 11, data integrity, and computer system validation. • Strong understanding of QC laboratory processes and workflows. • Strong analytical and problem-solving skills to identify and resolve technical issues related to lab systems, configurations, or integrations. Preferred Qualifications • Excellent communication and interpersonal skills to build relationships with stakeholders and articulate complex technical concepts. • Adaptability and flexibility to work in a fast-paced, dynamic environment and manage multiple tasks simultaneously. • Master's degree in Computer Science, Engineering, Chemistry, Life Sciences, or a related field. • Experience configuring LabVantage (workflows, specifications, stability, environmental monitoring) or administering Waters Empower (projects, custom fields, system policies). • Experience with instrument integration and data acquisition, including scientific data management systems (SDMS), middleware, and ed