Katalyst CRO
LIMS SME(Laboratory Information Management System Subject Matter Expert)
Katalyst CRO, Highland Heights, Kentucky, United States
Overview
We are seeking a highly experienced Laboratory Information Management System (LIMS) Subject Matter Expert (SME) with 10+ years of proven expertise in the implementation, optimization, and support of LIMS solutions within clinical and research laboratory environments. The ideal candidate will serve as a key bridge between laboratory users, IT teams, and LIMS vendors, ensuring the system meets operational needs, regulatory requirements, and business goals. Responsibilities
System Expertise & Leadership: Serve as the primary LIMS SME with deep knowledge of LIMS architecture, modules, and workflows including sample management, workflow automation, and data reporting. Implementation & Configuration: Lead installations, configurations, and system customizations to align LIMS with business requirements, clinical workflows, and regulatory compliance. Process Analysis & Optimization: Conduct end-to-end business process analysis, documenting current workflows and recommending optimized future-state solutions. Integration & Data Management: Manage LIMS integrations with analytical instruments, ELNs, ERP systems, and data warehouses; ensure data integrity, interoperability, and traceability. Stakeholder Engagement: Act as the primary liaison between laboratory staff, IT, and LIMS vendors; capture and prioritize user requirements, oversee vendor deliverables, and ensure timely resolution of system issues. Training, Documentation & Support: Develop and maintain user requirements documentation, SOPs, validation documents, and training materials; provide hands-on training and lead knowledge transfer sessions across global teams. Regulatory Compliance & Quality Assurance: Ensure LIMS meets regulatory standards (e.g., FDA 21 CFR Part 11, GxP, GLP, GMP, ISO guidelines); oversee system validation activities, risk assessments, and periodic audits. System Enhancements & Upgrades: Lead upgrade planning, testing, and deployment while minimizing operational disruption; leverage new product capabilities for continuous improvement. Requirements
Bachelor's or master's degree in Life Sciences, Biotechnology, Pharmaceutical Sciences, Chemistry, Computer Science, or related discipline. 10+ years of experience implementing, supporting, and optimizing LIMS in clinical and/or research laboratory environments. 5+ years of specialized expertise in: System configuration and customization (workflow design, master data setup, role/permission management). Integration of LIMS with instruments, ELNs, and ERP systems. Validation & compliance documentation (URS, FRS, validation protocols, traceability matrices, audit reports). Process analysis and optimization for laboratory operations; user training, SOP development, and system lifecycle documentation. Regulatory compliance with FDA 21 CFR Part 11, GLP, GMP, GAMP 5, ISO 17025, and data integrity principles. Strong experience bridging technical and business teams to deliver optimized solutions; excellent communication and vendor engagement skills; ability to manage multiple projects with global collaboration.
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We are seeking a highly experienced Laboratory Information Management System (LIMS) Subject Matter Expert (SME) with 10+ years of proven expertise in the implementation, optimization, and support of LIMS solutions within clinical and research laboratory environments. The ideal candidate will serve as a key bridge between laboratory users, IT teams, and LIMS vendors, ensuring the system meets operational needs, regulatory requirements, and business goals. Responsibilities
System Expertise & Leadership: Serve as the primary LIMS SME with deep knowledge of LIMS architecture, modules, and workflows including sample management, workflow automation, and data reporting. Implementation & Configuration: Lead installations, configurations, and system customizations to align LIMS with business requirements, clinical workflows, and regulatory compliance. Process Analysis & Optimization: Conduct end-to-end business process analysis, documenting current workflows and recommending optimized future-state solutions. Integration & Data Management: Manage LIMS integrations with analytical instruments, ELNs, ERP systems, and data warehouses; ensure data integrity, interoperability, and traceability. Stakeholder Engagement: Act as the primary liaison between laboratory staff, IT, and LIMS vendors; capture and prioritize user requirements, oversee vendor deliverables, and ensure timely resolution of system issues. Training, Documentation & Support: Develop and maintain user requirements documentation, SOPs, validation documents, and training materials; provide hands-on training and lead knowledge transfer sessions across global teams. Regulatory Compliance & Quality Assurance: Ensure LIMS meets regulatory standards (e.g., FDA 21 CFR Part 11, GxP, GLP, GMP, ISO guidelines); oversee system validation activities, risk assessments, and periodic audits. System Enhancements & Upgrades: Lead upgrade planning, testing, and deployment while minimizing operational disruption; leverage new product capabilities for continuous improvement. Requirements
Bachelor's or master's degree in Life Sciences, Biotechnology, Pharmaceutical Sciences, Chemistry, Computer Science, or related discipline. 10+ years of experience implementing, supporting, and optimizing LIMS in clinical and/or research laboratory environments. 5+ years of specialized expertise in: System configuration and customization (workflow design, master data setup, role/permission management). Integration of LIMS with instruments, ELNs, and ERP systems. Validation & compliance documentation (URS, FRS, validation protocols, traceability matrices, audit reports). Process analysis and optimization for laboratory operations; user training, SOP development, and system lifecycle documentation. Regulatory compliance with FDA 21 CFR Part 11, GLP, GMP, GAMP 5, ISO 17025, and data integrity principles. Strong experience bridging technical and business teams to deliver optimized solutions; excellent communication and vendor engagement skills; ability to manage multiple projects with global collaboration.
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