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LIMS SME(Laboratory Information Management System Subject Matter Expert)

LIMS SME(Laboratory Information Management System Subject Matter Expert)

cGxPServeHighland Heights, KY, United States
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Job Description :

  • 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.
  • This role requires advanced skills in business process analysis, system configuration, workflow automation, system integration, and user enablement, along with hands-on leadership in regulatory compliance and data integrity practices.

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.
  • Provide strategic guidance on LIMS best practices and future technology roadmaps.

    • Implementation & Configuration.

  • Lead installations, configurations, and system customizations to align LIMS with business requirements, clinical workflows, and regulatory compliance.
  • Design and implement workflow automation solutions for improved lab efficiency.

    • Process Analysis & Optimization.

  • Conduct end-to-end business process analysis, documenting current workflows and recommending optimized future-state solutions.
  • Translate laboratory needs into functional and technical specifications.

    • Integration & Data Management.

  • Manage LIMS integrations with analytical instruments, ELNs, ERP systems, and data warehouses.
  • Ensure data integrity, interoperability, and traceability across connected systems.

    • 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 to lab users and technical staff.
  • Lead knowledge transfer sessions across global teams.
  • Regulatory Compliance & Quality Assurance.
  • Ensure LIMS meets regulatory standards such as FDA 21 CFR Part 11, GxP, GLP, GMP, and ISO guidelines.
  • Oversee system validation activities, risk assessments, and periodic audits.

    • System Enhancements & Upgrades.

  • Lead system upgrade planning, testing, and deployment while minimizing operational disruption.
  • Leverage new product capabilities to drive continuous improvement.

    • Requirements :

  • Bachelor's or master's degree in Life Sciences, Biotechnology, Pharmaceutical Sciences, Chemistry, Computer Science, or related discipline.
  • Additional certifications in LIMS administration, Computer System Validation (CSV), GAMP 5, or Quality / Regulatory Compliance are highly desirable.
  • 10+ years of experience implementing, supporting, and optimizing LIMS in clinical and / or research laboratory environments.
  • 5+ years of specialized expertise in the following areas :
  • System configuration and customization (workflow design, master data setup, role / permission management).
  • Integration of LIMS with instruments (e.g., chromatography, spectroscopy, sequencing), 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 in bridging technical and business teams to deliver optimized solutions.
  • Excellent communication, stakeholder management, and vendor engagement skills.
  • Ability to manage multiple projects simultaneously with global team collaboration.
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    Information System • Highland Heights, KY, United States