Senior Engineer-Soln. Architect

Job Description About the Technology Organization:u202Fu00A0 Technology at Lilly builds andu00A0maintainsu00A0capabilities usingu00A0cutting edgeu00A0technologies like most prominent tech companies. What differentiates Technology at Lilly is that we create new possibilities through tech to advance our purpose u2013 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.u202Fu202Fu00A0 u202Fu00A0 About the Business Function:u202Fu00A0 From molecule to market, Global Manufacturing playsu00A0an important roleu00A0in every step along a productu2019s 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.u202Fu202Fu00A0 Global Manufacturingu00A0comprisesu00A0a core group of functions that contribute to the production and supply of high-quality products: Engineering Manufacturing Information & Control Systemsu00A0(Tech@Lilly)u00A0Quality & Labs,u00A0Technology Services/Manufacturing Science Global Health, Safety and Environment and Global Supply Chain.u202Fu00A0 Job Title:u00A0Senior Engineer / Solution Architect u2013 Advanced Methodology Automation & Empower Configurationu00A0 u00A0 The Senior Engineer / Architect willu00A0be responsible foru00A0the design, development, and deployment of analytical test methods for HPLC within the laboratory digital ecosystem. This includes configuring and managing Empower policies, integrating chromatography data with enterprise LIMS (e.g.,u00A0LabVantage), and driving automation and standardization of analytical method lifecycles.u00A0This role ensures that analytical workflows are compliant, efficient, and aligned with global laboratory digitalization and data integrity standards.u00A0 Key Responsibilities:u202Fu00A0 Whatu00A0youu2019llu00A0be doing:u202Fu00A0 u00A0u00A0u00A0u00A0u00A0Analytical Method Design & Configuration:u00A0 u00B7u00A0u00A0u00A0u00A0u00A0u00A0 Lead the creation, configuration, and lifecycle management of HPLC test methods in LIMS and Empower.u00A0 u00B7u00A0u00A0u00A0u00A0u00A0u00A0 Define method parameters, specifications, and chromatographic conditions (column, solvent, gradient, detector, etc.).u00A0 u00B7u00A0u00A0u00A0u00A0u00A0u00A0 Establish method templates to enable automated or semi-automated method build and versioning.u00A0 u00B7u00A0u00A0u00A0u00A0u00A0u00A0 Ensure all method configurations adhere to cGMP, ALCOA+, and company data integrity standards.u00A0 u00A0u00A0u00A0u00A0u00A0u00A0Empower System Configuration & Policy Management:u00A0 u00B7u00A0u00A0u00A0u00A0u00A0u00A0 Configure and manage Empower project templates, instrument policies, and user privileges.u00A0 u00B7u00A0u00A0u00A0u00A0u00A0u00A0 Define naming conventions, acquisition methods, processing methods, and reporting templates for HPLC workflows.u00A0 u00B7u00A0u00A0u00A0u00A0u00A0u00A0 Proficiencyu00A0in developing andu00A0validatingu00A0Empower custom fields and calculation logic for assay, impurity, and system suitability workflows, including conditional formulas and summary calculations.u202Fu00A0 u00B7u00A0u00A0u00A0u00A0u00A0u00A0 Ability to troubleshoot calculation issues and integrate custom fields seamlessly with processing methods and report methods in a compliantu00A0GxPu00A0environment.u202Fu00A0 u00B7u00A0u00A0u00A0u00A0u00A0u00A0 Implement andu00A0maintainu00A0Empower policies for chromatographic data processing, result calculation, and electronic signatures.u00A0 u00B7u00A0u00A0u00A0u00A0u00A0u00A0 Partner with Quality and IT teams to ensure Empower configuration aligns with validated system procedures and regulatory requirements.u00A0 u00A0u00A0u00A0u00A0u00A0u00A0u00A0Integration & Automation:u00A0 u00B7u00A0u00A0u00A0u00A0u00A0u00A0 Capability to create global method templates and copy to local Empower instances as part ofu202Fdeployment.u00A0 u00B7u00A0u00A0u00A0u00A0u00A0u00A0 Collaborate with LIMS and integration teams to map and automate method data exchange betweenu00A0LabVantageu00A0(or other LIMS) andu00A0Empower.u00A0 u00B7u00A0u00A0u00A0u00A0u00A0u00A0 Develop oru00A0validateu00A0automated workflows for method build, data capture, and result transfer between systems.u00A0 u00B7u00A0u00A0u00A0u00A0u00A0u00A0 Contribute to the digital method management strategy, including automated test method creation, versioning, and approval workflows.u00A0 u00A0u00A0u00A0u00A0u00A0u00A0Technical Leadership & Governanceu00A0 u00B7u00A0u00A0u00A0u00A0u00A0u00A0 Serve as the subject matter expert (SME) for HPLC method digitalization and Empower configuration.u00A0 u00B7u00A0u00A0u00A0u00A0u00A0u00A0 Establish best practices, templates, and governance standards for analytical method management across sites.u00A0 u00B7u00A0u00A0u00A0u00A0u00A0u00A0 Provide technical oversight for system changes, upgrades, and validation related to Empower or LIMS integrations.u00A0 u00B7u00A0u00A0u00A0u00A0u00A0u00A0 Mentor junior engineers and analysts on chromatography method lifecycle management and digital data flow.u00A0 u00A0u00A0u00A0u00A0u00A0u00A0Compliance & Validationu00A0 u00B7u00A0u00A0u00A0u00A0u00A0u00A0 Ensure all configurations and automation scripts areu00A0validatedu00A0and maintained in compliance withu00A0GxPu00A0and 21 CFR Part 11.u00A0 u00B7u00A0u00A0u00A0u00A0u00A0u00A0 Develop andu00A0maintainu00A0validation documentation (URS, FS, test scripts, trace matrices) for Empower and method automation tools.u00A0 u00B7u00A0u00A0u00A0u00A0u00A0u00A0 Participate in internal and external audits related to analytical system data integrity and validation.u00A0 How you will succeed:u202Fu00A0 u00B7u00A0u00A0u00A0u00A0u00A0u00A0 Reduction in manual method configuration effort and errors.u00A0 u00B7u00A0u00A0u00A0u00A0u00A0u00A0 Consistent application of Empower and LIMS method templates across sites.u00A0 u00B7u00A0u00A0u00A0u00A0u00A0u00A0 Improved data integrity, audit readiness, and automation maturity.u00A0 u00B7u00A0u00A0u00A0u00A0u00A0u00A0 Faster onboarding of new or updated test methods.u00A0 u00B7u00A0u00A0u00A0u00A0u00A0u00A0 Ensuring compliance with global digital lab governance and validation standards.u00A0 What you should bring:u202Fu00A0 u00B7u00A0u00A0u00A0u00A0u00A0u00A0 Deep technical understanding ofu00A0chromatographic method design and data management.u00A0 u00B7u00A0u00A0u00A0u00A0u00A0u00A0 Strongu00A0systemu00A0configuration and integration skillsu00A0(LIMS u2194 Empower).u00A0 u00B7u00A0u00A0u00A0u00A0u00A0u00A0 Analytical thinker who can translate lab method requirements into digital configurations.u00A0 u00B7u00A0u00A0u00A0u00A0u00A0u00A0 Strong collaboration and stakeholder engagement across Quality, IT, and Manufacturing functionsu00A0 Basic Qualifications and Experience Requirement:u202Fu00A0 u00B7u00A0u00A0u00A0u00A0u00A0u00A0 Bacheloru2019s oru00A0Masteru2019su00A0degree in Analytical Chemistry, Chemical Engineering, Pharmaceutical Sciences, or related field.u00A0 u00B7u00A0u00A0u00A0u00A0u00A0u00A0 12+ years of experience in a regulated pharmaceutical QC or R&D environment, with deepu00A0expertiseu00A0in HPLC and chromatography data systems (Empower preferred).u00A0 u00B7u00A0u00A0u00A0u00A0u00A0u00A0 Strong experience configuring Empower policies, projects, and processing methods.u00A0 u00B7u00A0u00A0u00A0u00A0u00A0u00A0 Hands-on experience with LIMS (LabVantageu00A0preferred), including test method setup and data integration.u00A0 u00B7u00A0u00A0u00A0u00A0u00A0u00A0 Knowledge of method validation principles (ICH Q2) and analytical data workflows.u00A0 u00B7u00A0u00A0u00A0u00A0u00A0u00A0 Proven understanding ofu00A0GxP, ALCOA+, Part 11, and data lifecycle management principles.u00A0 u00B7u00A0u00A0u00A0u00A0u00A0u00A0 Hands-on experience with JIRA, ALM, and ServiceNow (SNOW) for requirement tracking, defect management, and change control activities in regulated environments.u202Fu00A0 Additional Skills/Preferences:u202Fu00A0 u00B7u00A0u00A0u00A0u00A0u00A0u00A0 Experience with automation or integration tools (e.g., Talend, Boomi, Python, or Empower SDK).u00A0 u00A0 Additional Information:u00A0N/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 () 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. Lillyu00A0does 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