Advisor - Electronic Lab Systems (LabVantage LIMS / MES)

Company: Eli Lilly and Company
Location: Indianapolis
Posted on: July 10, 2025

Job Description:

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 seeking an Advisor/Senior Advisor, Electronic Laboratory Systems, to support its Global API Expansion Project. This role will provide quality assurance expertise in the implementation, validation, ongoing maintenance, and lifecycle management of electronic laboratory and manufacturing systems—including LIMS (e.g., LabVantage) and EBR systems (e.g., MES). The successful candidate will ensure these systems are designed, deployed, and managed in full compliance with global regulatory standards (FDA, EMA, ICH), industry guidelines (GAMP 5, 21CFR Part 11, EU Annex 11), and Lilly’s internal procedures. Candidates should possess a strong background in life sciences and information technology, coupled with proven experience supporting cGMP electronic systems within pharmaceutical manufacturing, particularly those related to APIs. Responsibilities: The Electronic Laboratory Systems Advisor/Sr. Advisor oversees the implementation, validation, and lifecycle management of electronic laboratory systems (such as LIMS and MES) at new Eli Lilly API Manufacturing sites. This position works with automation, QC labs, QA, and Tech@Lilly teams to develop compliance strategies, interpret validation requirements, maintain standards, provide inspection support, evaluate quality practices, ensure operational readiness, and compare validation processes. The role is responsible for system design, implementation, and lifecycle management of eLAB systems. Provides leadership in quality assurance and governance processes. Provides leadership or support in the implementation of LIMS and MES systems, drawing on prior experience with LabVantage and other LIMS platforms, as well as commercial EBS solutions such as MES. Collaborates with key stakeholders to capture business requirements and translate them into functional specifications. Oversees or prepares system design documentation, including URS, FRS, DS, configuration specifications, and data flow diagrams. Provides technical guidance on master data setup, workflows, system configuration, and reporting functions. Serves as subject matter expert in Quality, focusing on global and company-specific quality requirements for eLAB systems. Prepares, reviews, and approves GMP documentation (e.g., Non-Conformances, Procedures, Protocols, Specifications, and Change Controls) to ensure quality and user requirements are met. Establishes and maintains electronic laboratory systems quality assurance processes. Aligns with customers, company, and quality priorities to support implementation objectives. Participates in computer system validation (CSV), computer software assurance (CSA), and qualification activities according to GAMP 5 and 21 CFR Part 11. Maintains validation status and supports periodic reviews and change management processes. Ensures data integrity and regulatory compliance throughout the system lifecycle. Acts as the quality assurance representative or liaison for LIMS and MES system projects. Conducts investigations and impact assessments for deviations, audit findings, and system issues related to electronic systems. Supports internal and external audits and inspections by regulatory authorities such as the FDA and EMA. Takes part in governance boards related to digital quality systems. Trains and mentors users, QA reviewers, and administrators on system functionality and compliance requirements. Works with vendors and IT teams to facilitate system upgrades and support structures. Remains informed about industry trends and emerging technologies in digital quality systems. Basic Requirements: Bachelors degree in the life science or relevant technical field. Minimum of 8 years’ experience within the pharmaceutical or biotechnology industry, including at least 5 years supporting LIMS and/or MES systems. Demonstrated hands-on proficiency with LabVantage LIMS as well as MES platforms (i.e. Emerson Syncade, Werum PAS-X, or POMSnet). Additional Skills/Preferences: In-depth knowledge of FDA 21 CFR Part 11, Annex 11, ICH Q9/Q10, GAMP 5, and Data Integrity ALCOA guidelines. Advanced degree (MS/MA) or relevant certifications (PMP, GAMP, LEAN, ISPE/SCADA). Established track record in system implementation, validation, and compliance within regulated environments. Experience supporting GMP manufacturing or quality laboratories, preferably related to APIs or complex modalities. Ability to provide technical support, guidance, and training to relevant staff members. Skilled in generating reports and analyzing system performance metrics. Capable of supporting the development and deployment of system upgrades and enhancements. Demonstrated strong oral and written communication skills. Ability to work independently or as part of a team as well as with different cultures. Demonstrates leadership, communication, and decision making and planning skills. Experience leading LIMS and MES system implementations. Familiarity with LabVantage, and commercial EBS platforms like MES. Integration experience between LIMS/MES and enterprise systems (ERP, CDS, DCS, SCADA). Strong project management skills; able to handle multiple priorities. Certifications in LIMS and IT service management (e.g., ITIL). Additional Information: Up to 10% of domestic/international travel for deployment, validation, training, or audits at manufacturing sites. This role is an onsite role based in Indianapolis, Indiana. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( https://careers.lilly.com/us/en/workplace-accommodation ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $121,500 - $198,000 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. WeAreLilly

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