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Eli Lilly seeks a QC Labs Ops & LIMS Process Expert to join the Global Manufacturing & Quality Labs team in Hyderabad. This role bridges pharmaceutical quality control laboratory operations and technology delivery, translating scientific and regulatory processes into standardized LIMS workflows and digital solutions.
You will serve as a subject-matter expert for end-to-end pharmaceutical QC laboratory processes and LabVantage-enabled workflows. Key responsibilities include:
**QC Process Expertise & Harmonization**: Lead process mapping, fit-gap assessments, and standardization across global manufacturing sites. Identify justified local or regulatory variations. Facilitate global workshops with QC scientists, laboratory SMEs, Quality teams, product owners, and implementation partners to drive process decisions and adoption.
**LabVantage Implementation & Functional Design**: Participate across requirements, design, configuration review, demonstrations, testing, validation, and deployment readiness. Translate QC laboratory needs into functional requirements, process flows, user stories, and acceptance criteria. Review configurations for scientific fit, compliance, and alignment with global processes.
**Laboratory Processes & Master Data**: Provide expertise across sample receipt, specifications, analytical methods, results review, approval, and release workflows. Define and harmonize requirements for stability programs, sterility testing, environmental monitoring, investigations, and related QC workflows. Partner on master-data design, governance, creation, migration, and lifecycle maintenance.
**Connected Laboratory Process Design**: Define business-process and data requirements for connections between LabVantage and laboratory systems (Empower/CDS, MODA-EM, ELN/LES, MES, SAP, analytical instruments). Identify opportunities to reduce manual transcription and enable straight-through data flows.
**Testing, Validation & Deployment Readiness**: Develop business-process test scenarios and acceptance criteria. Support functional testing, UAT, validation, and defect triage. Partner with Quality and validation teams on intended use, requirements traceability, and process controls. Support site readiness, training, cutover planning, and hypercare.
**Governance, Data Integrity & Regulatory Compliance**: Apply GxP, data integrity, ALCOA+, 21 CFR Part 11, EU Annex 11, ICH expectations, and risk-based CSV/CSA principles to LIMS design. Ensure workflows address review, approval, audit trails, electronic records, and traceability. Support inspection readiness and provide expertise during USFDA, EMA/EMEA, and other regulatory audits.
Lilly is a global pharmaceutical company headquartered in Indianapolis with over 50,000 employees. Technology at Lilly is core to operations, innovation, and delivery—from drug discovery to clinical trials to enterprise systems. The Hyderabad site builds cloud platforms, AI systems, and enterprise-scale automation in service of life-changing medicines.
**Requirements**:
- Bachelor's or Master's degree in Analytical Chemistry, Chemistry, Microbiology, Biotechnology, Pharmaceutical Sciences, Life Sciences, Engineering, or related discipline
- 6–12 years of relevant experience
- Deep pharmaceutical or biotechnology QC laboratory-process expertise
- Hands-on understanding of LIMS-enabled laboratory workflows and experience participating in LabVantage or comparable enterprise LIMS implementation
- Strong experience with process harmonization, fit-gap analysis, functional requirements, laboratory master data, testing/UAT, validation, and deployment readiness
- Practical knowledge of stability, sterility, environmental monitoring, sample management, analytical testing, specifications, results review, investigations, and release-support processes
- Understanding of scientific processes performed on common QC laboratory equipment and how results, metadata, controls, and exceptions are managed
- Understanding of business and data flows involving Empower/CDS, MODA-EM, MES, SAP, ELN/LES, instruments, or related laboratory applications
- Strong facilitation, stakeholder management, global collaboration, problem-solving, and change-adoption skills
- Strong understanding of GxP, data integrity, CSV/CSA, ICH expectations, and regulatory inspection expectations for laboratory computerized systems
**Preferred Experience**:
- LabVantage implementation, harmonization, deployment, or process-design experience
- Multi-site or global QC process standardization and laboratory master-data harmonization
- Experience with Empower/CDS, MODA-EM, MES, SAP, stability, sterility, or environmental-monitoring workflows
- Experience supporting USFDA, EMA/EMEA, or comparable inspections involving QC processes or laboratory computerized systems
