QC Lab Systems Analyst

Eli Lilly and Company • Pleasant Prairie, WI

1d • Onsite

About The Position

The QC Lab Systems Analyst delivers, integrates, and supports computerized systems used in the Lilly Kenosha Quality Control laboratories, including LIMS, CDS, and laboratory instrument integrations. The analyst partners with QC laboratories, Quality Assurance, and global Tech@Lilly teams to ensure systems are reliable, compliant, and support right-first-time testing and timely batch release. At the P3 level, the role serves as technical lead for QC lab systems workstreams, owns solution design and integration decisions for the area, and mentors team members.

The position is based on-site in the Pleasant Prairie, Wisconsin area at Lilly’s manufacturing site. The site is designed to use advanced, integrated, and automated manufacturing systems for injectable medicines, device assembly, and packaging, with a focus on minimizing environmental impact. The role is Monday through Friday, with flexibility needed to support laboratory and production schedules, shutdowns, and occasional extended-hour or off-hour work. Travel to other U.S. and global Lilly sites may be required.

Requirements

• Bachelor's degree in Computer Science, Engineering, Chemistry, Life Sciences, or a related field.
• At least 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, such as 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 involving lab systems, configurations, or integrations.
• Ability to work on-site in the Pleasant Prairie, Wisconsin area.
• Flexibility to support laboratory testing and production schedules, shutdowns, and occasional extended-hour or off-hour work.
• Ability to travel to other U.S. and global Lilly sites as required.

Nice To Haves

• Excellent communication and interpersonal skills to build stakeholder relationships and explain complex technical concepts.
• Adaptability and flexibility in a fast-paced, dynamic environment, with the ability to manage multiple tasks simultaneously.
• Master's degree in Computer Science, Engineering, Chemistry, Life Sciences, or a related field.
• Experience configuring LabVantage workflows, specifications, stability, or environmental monitoring, or administering Waters Empower projects, custom fields, or system policies.
• Experience with instrument integration and data acquisition, including scientific data management systems (SDMS), middleware, and edge connectivity platforms.
• Experience integrating lab systems with ERP, such as SAP S/4HANA Quality Management, and MES.
• Experience with IT service management frameworks such as ITIL and tools such as ServiceNow.
• Understanding of cybersecurity concepts and best practices for laboratory systems and networked instruments.
• Experience with Agile or LEAN methodologies.
• Experience deploying lab systems at a new or expanding manufacturing site.
• Exposure to international operations, diverse teams, global IT projects, or work in a global organization.
• Proficiency with SQL and scripting languages such as Python or JavaScript.

Responsibilities

• Design, configure, implement, enhance, and maintain QC laboratory systems, including LIMS, CDS, and laboratory instrument data systems.
• Translate QC laboratory requirements—including 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 such as SAP S/4HANA and MES, using site edge connectivity and global integration patterns.
• Monitor emerging laboratory digital technologies and recommend applications at the site.
• 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, 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.
• Ensure QC lab systems comply with 21 CFR Part 11, EU Annex 11, GMP requirements, ALCOA+ data integrity principles, Lilly policies and procedures, and local procedures.
• Own risk-based computer system validation deliverables 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 a QC lab systems subject matter expert during internal and external inspections and ensure timely execution of findings management.
• Collaborate with QC Chemistry, QC Microbiology, Quality Assurance, Engineering, global Tech@Lilly lab systems teams, and vendors to improve laboratory operations.
• Influence the business to drive value and implement appropriate digital solutions.
• Mentor and develop lab systems team members.
• Represent the site in network and global lab systems forums and benchmark solutions inside and outside Lilly.

Benefits

• Company bonus, depending in part on company and individual performance.
• Company-sponsored 401(k) participation eligibility.
• Pension.
• Vacation benefits.
• Medical, dental, vision, and prescription drug benefits eligibility.
• Flexible benefits, including healthcare and/or dependent day care flexible spending accounts.
• Life insurance and death benefits.
• Certain time off and leave of absence benefits.
• Well-being benefits, including an employee assistance program, fitness benefits, and employee clubs and activities.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior