Senior Consultant - Manufacturing and Quality Systems

Senior Consultant – Manufacturing & Quality

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 modern capabilities, using leading-edge tools to advance our purpose—creating 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:  

From molecule to market, Global Manufacturing supports every step of a product’s 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: Senior Consultant – Manufacturing & 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:  

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

·       Deliver solutions aligned to enterprise IT and QC Lab goals

·       Plan releases/changes and influence lifecycle/architecture decisions.

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

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

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

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

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

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

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

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

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

·       Experience on data Enrichment activities as per the Business data review.

Automation & Digital Integration 

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

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

·       LAC/E Deployment, Build and Release management with automations. 

·       Empower with LACE Instrumentations.

·       SmartLab / Empower Process optimisations

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

 Governance, Validation & Documentation 

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

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

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

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

 Leadership & Collaboration 

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

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

·       Drive continuous improvement through automation, standard templates, and adoption of emerging technologies (AI/ML-assisted method generation, smart drivers). 

How you will succeed:  

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

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

·       Enable analytics-ready, high-quality laboratory data.

What you should bring:  

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

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

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

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

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

·       Hands-on Experience with LabVantage LIMS configuration and interface development

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

·       Experience with reporting technologies such as Jasper reports and Crystal reports.

·       Strong database & SQL knowledge

·       Understanding of analytical lab workflows and instruments. 

·       Experience writing and updating technical documentations, SOPs and Knowledge articles.

·       Ability to work across global teams (IT, Quality, Lab Operations). 

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

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

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

Basic Qualifications and Experience Requirement:  

·       Bachelor’s or master’s degree in computer science, Instrumentation, Chemical Engineering, Analytical Chemistry, or related field. 

·       10 years of experience in laboratory informatics, preferably in the pharma, biotech, or chemicals industry. 

·       5+ years of hands-on experience on Lab Systems (i.e. SmartLab, LV LIMS) and chromatography and analytical instrument systems (Empower, Chromeleon, Microplate readers, etc.). 

·       Proven experience with any instrument integration and driver development, Java, XML, or REST APIs. 

·       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 on any Lab Solution 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

Experience Level

Senior Level