AI Solution Architect - MQ DIA

Architect multi-agent orchestration systems (LangGraph, AutoGen, CrewAI) for manufacturing workflows: deviation investigation, complaint triage, CAPA recommendation, and batch release support.

Design enterprise RAG architectures across QMS, MES, and regulatory knowledge bases with retrieval fidelity, hybrid search, and audit-ready provenance.

Define MCP server architecture standards for exposing manufacturing APIs (Veeva, MES, LIMS) as structured LLM-consumable tool interfaces.

Architect real-time analytics on OSI PI / Kafka streams for predictive quality, OEE optimization, and process excursion detection.

Own cloud architecture strategy across AWS, Azure, and Databricks — ensuring security posture, GxP compliance, and cost governance.

Design the data lake integration layer: medallion architecture (Bronze/Silver/Gold), data contracts, schema registries, and lineage governance on Delta Lake.

Define MLOps architecture: model registry (MLflow), drift detection, retraining pipelines, and model lifecycle governance.

Govern MuleSoft + MCP integration patterns — clean separation between legacy integration investments and new AI tooling layers.

Serve as AI governance authority: model explainability, audit trails, human-in-the-loop gates, and regulatory defensibility of AI-assisted decisions.

Lead CSV framework design for AI/ML systems under 21 CFR Part 11, EU Annex 11, and GAMP 5 — including IQ/OQ/PQ templates and risk-based validation strategies.

Engage Global QA, Regulatory Affairs, and IT Risk to qualify new AI capabilities for GxP manufacturing environments.

Mentor distributed AI engineering and platform architecture teams; define engineering standards and review processes.

Represent MQ DIA in enterprise AI governance forums, architecture councils, and with executive stakeholders across Manufacturing, Quality, and Regulatory.

Partner with HR to define hiring profiles and skill frameworks for the MQ AI engineering community.

Hands-on experience with Veeva QMS, QBDVision, OSI PI, MES (Tulip, Werum PAS-X), or LabVantage / STARLIMS.

Familiarity with AI Gateway platform, Lakehouse/Databricks environment, or MuleSoft integration architecture.

Knowledge of FDA AI/ML-based SaMD guidance, ICH Q8–Q10, and data mesh / ontology engineering.

Certifications: AWS Solutions Architect Pro, Azure Solutions Architect Expert, Databricks ML Professional.

At Lilly, caring is not only what we do for patients. It is how we work. We believe the people who dedicate themselves to making medicines better deserve an environment that makes their lives better too, one where they are supported, respected, and given the space to do their best work. This is not just a policy. It is who we are.

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 an EEO/Affirmative Action Employer and 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.

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.