Senior Engineer-Soln. Architect

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. About the Technology Organization: Technology at Lilly builds and maintains capabilities using cutting edge technologies like most prominent tech companies. What differentiates Technology at Lilly is that we create new possibilities through tech to advance our purpose creating medicines that make life better for people around the world, like data driven drug discovery and connected clinical trials. We hire the best technology professionals from a variety of backgrounds, so they can bring an assortment of knowledge, skills, and diverse thinking to deliver innovative solutions in every area of the enterprise. About the Business Function: From molecule to market, Global Manufacturing plays an important role in every step along a product's lifecycle. Most of our customers never see the scientific and technical resources behind our medicines. But customers experience, every day, the performance of our high-quality products and global supply network. Global Manufacturing comprises a core group of functions that contribute to the production and supply of high-quality products: Engineering; Manufacturing Information & Control Systems (Tech@Lilly); Quality & Labs, Technology Services/Manufacturing Science; Global Health, Safety and Environment; and Global Supply Chain. Job Title:Senior Engineer / Solution Architect LabVantageTest Method Development & Instrument Integration The Senior Engineer / Architect will be responsible for designing, building, and automating analytical test methods and associated data and specifications within LabVantage LIMS, and for developing or overseeing the development of instrument drivers and integrations that enable direct data capture from laboratory instruments. This role combines deep domain expertise in laboratory processes and analytical methods with technical leadership in LIMS master data configuration, SDK development, and instrument connectivity. The incumbent will play a key role in advancing the organization's digital laboratory ecosystem, driving data integrity, automation, and compliance in GxP systems. Key Responsibilities: Whatyou'llbe doing: LabVantageTest Method Design & Build - Lead the configuration, creation, and lifecycle management of analytical test methods in LabVantage LIMS (e.g., Instruments such as HPLC, GC, dissolution, titration, and spectroscopic methods). - Design test templates, specifications, and parameter lists ensuring standardization and scalability across products and sites. - Define and maintain Test method metadata structures for automation (units, limits, calculations, result entry templates). - Implement Test method versioning, review, and approval workflows aligned with corporate data governance and validation policies. - Partner with functional experts to ensure test methods comply with GxP, ALCOA+, and analytical method validation principles. - Build test scenarios/ documents and Test method templates Instrument Driver Development & Integration - Collaborate with instrumentation and IT teams to design and implement instrument interfaces (e.g., Empower, Chromeleon, Agilent OpenLab, Darwin, SmartLab). - Oversee or contribute to SDK-based driver development to enable direct data capture and bidirectional communication with LabVantage (e.g. Talend open studio, etc ). - Define data mapping, file parsing, and communication protocols for automated result upload from instruments into LIMS. - Partner with instrument vendors and LabVantage technical teams for new instrument onboarding and driver enhancements. - Stand-alone instrument driver builds and testing. Automation & Digital Integration - Design automation frameworks to reduce manual effort in test method setup and instrument data handling. - Contribute to or lead integration architecture for LIMS CDS QMS Data Lake connections using APIs or middleware (MuleSoft, Boomi, Talend, etc.). - Support initiatives for automated test method build from structured templates or upstream systems (ERP/PLM). - Collaborate with data analytics teams to make instrument and method data analytics-ready for dashboards and trending. Governance, Validation & Documentation - Ensure all configurations and driver builds are validated, version-controlled, and auditable as part of GxP compliance and following regulatory and Lilly IT quality standards (CSV-Computer System Validation). - Create and maintain design documents, configuration specifications, source code reviews (Drivers only) and technical SOPs for test method and driver management. - Support QA in CSV, change control, and periodic review activities. - Participate in audits and ensure all integrations and automation components meet 21 CFR Part 11 and Annex 11 requirements. Leadership & Collaboration - Serve as the technical SME for LabVantage test method management and instrument integration. - Provide mentorship and guidance to junior engineers or site-level LabVantage administrators. - Partner with global digital, quality, and IT stakeholders to define and enforce standards for method and instrument onboarding. - Drive continuous improvement through automation, template standardization, and adoption of emerging technologies (AI/ML-assisted method generation, smart drivers). How you will succeed: - Reduced manual effort and faster deployment of new test methods. - Standardized and validated instrument integration architecture. - Improved data flow between LabVantage and analytical instruments. - Compliance with global lab data governance and validation standards. - Enablement of analytics-ready, high-quality laboratory data. What you should bring: - Strong analytical and systems thinking. - Technical proficiency in LIMS development and configuration, scripting, and API-based integrations. - Understanding of analytical lab workflows and instruments. - Excellent documentation and communication skills. - Ability to work across global teams (IT, Quality, Lab Operations). - Strategic mindset to connect lab automation initiatives with enterprise digital goals. Basic Qualifications and Experience Requirement: - Bachelor's or Master's degree in Computer Science, Instrumentation, Chemical Engineering, Analytical Chemistry, or related field. - 12+ years of experience in laboratory informatics, preferably in the pharma, biotech, or chemicals industry. - 5+ years of hands-on experience configuring and deploying LabVantage LIMS (test methods, specifications, calculations, and workflows). - Proven experience with instrument integration and driver development, ideally using LabVantage SDK, Java, XML, or REST APIs. - Experience integrating LabVantage with chromatography and analytical instrument systems (Empower, Chromeleon, Microplate readers, etc.). - Strong knowledge of GxP, 21 CFR Part 11, and data integrity principles (ALCOA+). - Familiarity with ETL/middleware tools and system validation (CSV/SDLC) practices. - Exposure to data analytics or digital lab transformation projects is a plus. - Hands-on experience with JIRA, ALM, and ServiceNow (SNOW) for requirement tracking, defect management, and change control activities in regulated environments. - Certification in LabVantage Administration and/or Stability, SDMS from LabVantage solutions is preferred. Additional Skills/Preferences:N/A 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 does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status. #WeAreLilly