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Largeton Group · 3 months ago

Laboratory Information Management System (LIMS) SME

Highland Heights, KY

Full-time

Hybrid

Senior Level

Largeton Group is seeking a Laboratory Information Management System (LIMS) Subject Matter Expert (SME) to provide strategic direction and expertise in LIMS architecture and workflows. The role involves leading the installation and customization of LIMS, managing integrations with laboratory instruments, and ensuring compliance with regulatory standards.

ConsultingInformation TechnologyTraining

H1B Sponsor Likely

Responsibilities

Serve as the primary Subject Matter Expert (SME) for Laboratory Information Management System (LIMS), providing strategic direction and expertise in LIMS architecture, modules, and workflows

Lead installation, configuration, customization, and system upgrades of LIMS to align with business, clinical, and regulatory requirements

Analyze and optimize laboratory processes, translating lab needs into functional and technical specifications

Manage integration of LIMS with laboratory instruments, Electronic Lab Notebooks (ELNs), ERP systems, and data warehouses, ensuring data integrity and interoperability

Act as the main liaison among laboratory staff, IT teams, and LIMS vendors to capture requirements and oversee system deliverables

Develop and maintain comprehensive documentation, SOPs, validation documents, and training materials

Provide training and lead knowledge transfer sessions for laboratory and technical teams

Ensure LIMS compliance with regulatory standards (FDA 21 CFR Part 11, GLP, GMP, ISO, etc.), oversee system validation, risk assessment, and audits

Drive continuous system improvements and upgrades with minimal operational disruption

Collaborate with global teams and manage multiple projects concurrently, ensuring effective communication with all stakeholders

Qualification

LIMS expertiseSystem integrationRegulatory complianceDocumentation developmentTraining skills

Required