QC Labs Ops & LIMS Process Expert
Eli Lilly and CompanyMatch Score
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Job Description
Structured overview of role & requirementsAbout This Role
Own and lead process mapping, harmonization, and standardization of pharmaceutical QC laboratory processes and LIMS workflows across global manufacturing sites.
Translate scientific and quality control laboratory needs into clear functional requirements, workflows, test scenarios, and master data for LabVantage LIMS deployment and connected laboratory solutions.
Support validation, testing, deployment readiness, regulatory compliance, and continuous improvement of LIMS-enabled QC processes ensuring data integrity and inspection readiness.
Minimum Requirements
Bachelor's or Master's degree in Analytical Chemistry, Chemistry, Microbiology, Biotechnology, Pharmaceutical Sciences, Life Sciences, Engineering, or related field.
6-12 years relevant experience in pharmaceutical or biotechnology QC laboratories, laboratory systems, LIMS implementation, or digital transformation.
Hands-on experience or participation in LabVantage or comparable enterprise LIMS implementations, including process harmonization and functional design.
Strong knowledge of GxP, data integrity (ALCOA+), 21 CFR Part 11, EU Annex 11, and regulatory inspection expectations for laboratory computerized systems.
Ideal Candidate Profile
Experienced in global or multi-site QC process standardization and laboratory master-data governance within pharmaceutical manufacturing environments.
Proficient in translating complex scientific QC processes and laboratory equipment workflows into standardized LIMS configurations and user stories.
Skilled at collaborating with cross-functional teams including QC, Quality, Technology, validation, and implementation partners to drive harmonized, compliant LIMS deployment and regulatory inspection readiness.