Senior Consultant \u2013 Manufacturing & Quality

About the Technology Organization:u202Fu202Fu00A0

Technology at Lilly builds and maintains modern capabilities, using leading-edge tools to advance our purposeu2014creating medicines that make life better worldwide. We enable data-driven drug discovery, connected clinical trials, and enterprise innovation by hiring diverse, top technology talent to deliver solutions across the business.

About the Business Function:u202Fu00A0

From molecule to market, Global Manufacturing supports every step of a productu2019s lifecycle. While customers may not see the work behind our medicines, they rely daily on the performance of our high-quality products and global supply network.

Global Manufacturing includes Engineering Manufacturing Information & Control Systems (Tech@Lilly) Quality & Labs Technology Services/Manufacturing Science Global Health, Safety and Environment and Global Supply Chain.

Job Title:u00A0Senioru00A0Consultant u2013u00A0Manufacturing & Quality

The Senior Consultant (Manufacturing & Quality) supports the Global Lab organization by deploying and sustaining custom and commercial lab solutions (e.g., SmartLab, CIMS, Empower with LAC/E). The role also drives visualizations and process optimization through automation.

The Global Lab Information and Data Solutions (IDS) team delivers and maintains applications for Global Lab and is part of the Manufacturing & Quality IDS organization, supporting digital-plant transformation and operational excellence through technology and analytics.

IDS partners with central and site teams to define needs and deliver support for the lab application portfolio (e.g., SmartLab, Empower, LabVantage LIMS, LES, ELN, and lab intelligence solutions).

Key Responsibilities:u202Fu00A0

u00B7u00A0u00A0u00A0u00A0u00A0u00A0u00A0Deploy, configure, integrate, and support lab systems (e.g., SmartLab, CIMS, Empower/LAC/E, and LabVantage LIMS), including interface development.

u00B7u00A0u00A0u00A0u00A0u00A0u00A0u00A0Deliver solutions aligned to enterprise IT and QC Lab goals

u00B7u00A0u00A0u00A0u00A0u00A0u00A0u00A0Plan releases/changes and influence lifecycle/architecture decisions.

u00B7u00A0u00A0u00A0u00A0u00A0u00A0u00A0Define validation/test strategy (including automation), ensure compliance with Lilly standards/quality rules, and produce/oversee validation documentation.

u00B7u00A0u00A0u00A0u00A0u00A0u00A0u00A0Partner with GQL leadership, site IT, enterprise architecture, vendors, and external partners on cross-organizational initiatives.

u00B7u00A0u00A0u00A0u00A0u00A0u00A0u00A0Resolve incidents/problems and oversee Tier 1 support enable analytics via reports/dashboards manage vendors (proposals, estimates, negotiation).

u00B7u00A0u00A0u00A0u00A0u00A0u00A0u00A0Configure, tailor, and maintain LabVantage LIMS Master data throughout various modules including sample management, test methods, specifications, stability studies, instrument management, labels, and reporting functions.

u00B7u00A0u00A0u00A0u00A0u00A0u00A0u00A0Design and oversee master data models, hierarchies, and workflows that facilitate standardized business processes.

u00B7u00A0u00A0u00A0u00A0u00A0u00A0u00A0Establish user roles or job types, privileges, and security models in accordance with global and site-level governance standards.

u00B7u00A0u00A0u00A0u00A0u00A0u00A0u00A0Perform end to end master data setup of AQM in GLIMS LabVantage including Product, Product Variant, Product Variant rule and Sampling Plan

u00B7u00A0u00A0u00A0u00A0u00A0u00A0u00A0Create and Configure Tests including Test Methods, Parameter Lists, Specifications and Limit Rules.

u00B7u00A0u00A0u00A0u00A0u00A0u00A0u00A0Collaborate with system owners, Laboratory teams and IT stakeholders to align system capabilities with business needs

u00B7u00A0u00A0u00A0u00A0u00A0u00A0u00A0Experience on data Enrichment activities as per the Business data review.

Automation & Digital Integrationu00A0

u00B7u00A0u00A0u00A0u00A0u00A0u00A0u00A0Build automation to reduce manual operational work (e.g., access provisioning, deployments, and release activities).

u00B7u00A0u00A0u00A0u00A0u00A0u00A0u00A0Improve Smart Lab/Empower processes and instrument integration support global initiatives such as LIMS implementations.

u00B7u00A0u00A0u00A0u00A0u00A0u00A0u00A0LAC/E Deployment, Build and Release management with automations.u00A0

u00B7u00A0u00A0u00A0u00A0u00A0u00A0u00A0Empower with LACE Instrumentations.

u00B7u00A0u00A0u00A0u00A0u00A0u00A0u00A0SmartLab / Empower Process optimisations

u00B7u00A0u00A0u00A0u00A0u00A0u00A0u00A0Contribute to integration architecture across LIMS/CDS/QMS/Data Lake using APIs or middleware (e.g., MuleSoft, Boomi, Talend)

u00A0Governance, Validation & Documentationu00A0

u00B7u00A0u00A0u00A0u00A0u00A0u00A0u00A0Support access governance (MyAccess roles) and lab system deployments in line with site onboarding requirements.

u00B7u00A0u00A0u00A0u00A0u00A0u00A0u00A0Execute CAPA/problem/incident/change processes and apply ITIL practices in regulated environments.

u00B7u00A0u00A0u00A0u00A0u00A0u00A0u00A0Maintain GxP/CSV compliance and documentation (design/config specs, SOPs) support QA change control and periodic reviews.

u00B7u00A0u00A0u00A0u00A0u00A0u00A0u00A0Participate in audits and ensure integrations/automation meet 21 CFR Part 11 and Annex 11 requirements.

u00A0Leadership & Collaborationu00A0

u00B7u00A0u00A0u00A0u00A0u00A0u00A0u00A0Serve as a technical SME for lab systems and instrument integrations, coach site admins and local IT.

u00B7u00A0u00A0u00A0u00A0u00A0u00A0u00A0Partner with global digital, quality, and IT stakeholders to define standards for method and site onboarding.

u00B7u00A0u00A0u00A0u00A0u00A0u00A0u00A0Drive continuous improvement through automation, standard templates, and adoption ofu00A0emerging technologies (AI/ML-assisted method generation, smart drivers).u00A0

How you will succeed:u202Fu00A0

u00B7u00A0u00A0u00A0u00A0u00A0u00A0u00A0Reduce manual effort and speed deployments across interconnected lab systems through standard, automated, and validated releases.

u00B7u00A0u00A0u00A0u00A0u00A0u00A0u00A0Provide SME support for lab system integrations/migrations and maintain compliance with global data governance and validation standards.

u00B7u00A0u00A0u00A0u00A0u00A0u00A0u00A0Enable analytics-ready, high-quality laboratory data.

What you should bring:u202Fu00A0

u00B7u00A0u00A0u00A0u00A0u00A0u00A0u00A0Strong hands-on experience in Lab Informatics Systems (e.g. SmartLab, CIMS and Empower)

u00B7u00A0u00A0u00A0u00A0u00A0u00A0u00A0Exposure to or working knowledge of Smart Lab solutions, including basic configuration, master data setup, or laboratory workflows.

u00B7u00A0u00A0u00A0u00A0u00A0u00A0u00A0Familiarity with laboratory data management concepts in Darwin LIMS, with an understanding of data integrity, traceability, and GxP compliance expectations

u00B7u00A0u00A0u00A0u00A0u00A0u00A0u00A0Experience working with Chromatography Data Systems (CDS) such as Empower, Chromeleon, or similar platforms for data acquisition, processing, and reporting.

u00B7u00A0u00A0u00A0u00A0u00A0u00A0u00A0Ability to support CDS master data management, configuration, or system validation activities, in collaboration with laboratory and quality teams.

u00B7u00A0u00A0u00A0u00A0u00A0u00A0u00A0Hands-on Experience with LabVantage LIMS configuration and interface development

u00B7u00A0u00A0u00A0u00A0u00A0u00A0u00A0Good working knowledge and understanding of LabVantage Master data management, migration and deployment throughout environments.

u00B7u00A0u00A0u00A0u00A0u00A0u00A0u00A0Experience with reporting technologies such as Jasper reports and Crystal reports.

u00B7u00A0u00A0u00A0u00A0u00A0u00A0u00A0Strong database & SQL knowledge

u00B7u00A0u00A0u00A0u00A0u00A0u00A0u00A0Understanding of analytical lab workflows and instruments.u00A0

u00B7u00A0u00A0u00A0u00A0u00A0u00A0u00A0Experience writing and updating technical documentations, SOPs and Knowledge articles.

u00B7u00A0u00A0u00A0u00A0u00A0u00A0u00A0Ability to work across global teams (IT, Quality, Lab Operations).u00A0

u00B7u00A0u00A0u00A0u00A0u00A0u00A0u00A0Hands-on experience managing master data governance activities, including model definition, maintenance, and auditing, to ensure data integrity, traceability, and compliance.

u00B7u00A0u00A0u00A0u00A0u00A0u00A0u00A0Experience performing master data imports and migrations across multiple environments through CMT and CTT, ensuring data accuracy, consistency, and integrity.u00A0

u00B7u00A0u00A0u00A0u00A0u00A0u00A0u00A0Proven ability to develop, configure, and enhance data file definitions to support master data maintenance and governance activities.

Basic Qualifications and Experience Requirement:u202Fu00A0

u00B7u00A0u00A0u00A0u00A0u00A0u00A0u00A0Bacheloru2019s or masteru2019s degree in computer science, Instrumentation, Chemical Engineering, Analytical Chemistry, or related field.u00A0

u00B7u00A0u00A0u00A0u00A0u00A0u00A0u00A010 years of experienceu00A0in laboratory informatics, preferably in theu00A0pharma, biotech, or chemicals industry.u00A0

u00B7u00A0u00A0u00A0u00A0u00A0u00A0u00A05+ years of hands-on experience on Lab Systems (i.e. SmartLab, LV LIMS) and chromatography and analytical instrument systemsu00A0(Empower,u00A0Chromeleon,u00A0Microplate readers, etc.).u00A0

u00B7u00A0u00A0u00A0u00A0u00A0u00A0u00A0Proven experience withu00A0any instrument integration and driver development, Java, XML, or REST APIs.u00A0

u00B7u00A0u00A0u00A0u00A0u00A0u00A0u00A0Strong knowledge ofu00A0GxP,u00A021 CFRu00A0Part 11, and data integrity principles (ALCOA+).u00A0

u00B7u00A0u00A0u00A0u00A0u00A0u00A0u00A0Familiarity withu00A0ETL/middleware toolsu00A0andu00A0system validation (CSV/SDLC)u00A0practices.u00A0

u00B7u00A0u00A0u00A0u00A0u00A0u00A0u00A0Exposure tou00A0data analytics or digital lab transformationu00A0projects is a plus.u00A0

u00B7u00A0u00A0u00A0u00A0u00A0u00A0u00A0Hands-on experience with JIRA, ALM, and ServiceNow (SNOW) for requirement tracking, defect management, and change control activities in regulated environments.u202Fu00A0

u00B7u00A0u00A0u00A0u00A0u00A0u00A0u00A0Certification on any Lab Solution is preferred.u202Fu00A0

Additional Skills/Preferences:u202FN/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.