Lead LIMS Consultant

Lead LIMS implementation, migration, upgrade, and support projects. Gather business requirements and define technical solutions. Design, configure, and customize LIMS workflows and functionalities. Oversee system integrations with laboratory instruments and enterprise systems. Prepare and review validation documents including URS, FS, DS, IQ, OQ, PQ, and test scripts. Ensure compliance with regulatory and quality standards. Manage project deliveries, timelines, risks, and stakeholder communications. Provide technical leadership and guidance to project teams. Support production issues and drive continuous improvement initiatives. Conduct user training and knowledge transfer sessions.
Strong experience in LIMS (LabWare / LabVantage / STARLIMS). Expertise in LIMS architecture, configuration, customization, and administration. Experience in end-to-end LIMS implementation and upgrade projects. Strong knowledge of laboratory operations, sample management, and quality processes. Experience with SQL, Oracle, SQL Server, and database management. Hands-on experience with instrument integration and middleware solutions. Knowledge of GxP, GMP, GLP, FDA 21 CFR Part 11, and validation practices. Experience in system integration with ERP, ELN, MES, and other enterprise applications. Strong stakeholder management and client-facing experience. Leadership experience in managing teams and mentoring junior consultants
Experience in Pharmaceutical, Life Sciences, Biotechnology, Chemical, or Healthcare industries. Exposure to Agile and Waterfall project methodologies. Strong analytical, communication, and problem-solving skills. Experience in global customer engagement and delivery models.

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