LIMS SMELaboratory Information Management System Subject Matter Expert

Kentucky, Highland Heights

09/25/2025

Contract

Active

Job Summary

We are seeking a highly experienced LIMS Subject Matter Expert (SME) with over 10 years of expertise in implementing, optimizing, and supporting Laboratory Information Management Systems within clinical and research environments.

This role serves as a strategic bridge between laboratory users, IT teams, and LIMS vendors, ensuring the system meets operational, regulatory, and business requirements.

The ideal candidate will possess advanced skills in system configuration, workflow automation, integration, and regulatory compliance.

Key Responsibilities

• Serve as the primary SME for LIMS architecture, modules, and workflows including sample management, automation, and reporting.
• Provide strategic guidance on LIMS best practices and future technology roadmaps.

• Lead installations, configurations, and customizations to align LIMS with business and regulatory needs.
• Design and implement workflow automation solutions to enhance laboratory efficiency.

• Conduct end-to-end business process analysis and recommend optimized future-state solutions.
• Translate laboratory requirements into functional and technical specifications.

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

• Act as the liaison between laboratory staff, IT teams, and LIMS vendors.
• Capture and prioritize user requirements and oversee vendor deliverables.

• Develop and maintain documentation including user requirements, SOPs, validation protocols, and training materials.
• Provide hands-on training and lead knowledge transfer sessions across global teams.

• Ensure compliance with FDA 21 CFR Part 11, GxP, GLP, GMP, ISO standards, and data integrity principles.
• Oversee system validation, risk assessments, and periodic audits.

• Lead planning, testing, and deployment of system upgrades with minimal disruption.
• Leverage new product capabilities to drive continuous improvement.

• Bachelor’s or Master’s degree in Life Sciences, Biotechnology, Pharmaceutical Sciences, Chemistry, Computer Science, or a related discipline.
• 10+ years of experience implementing and supporting LIMS in clinical or research environments.
• 5+ years of specialized expertise in:
• System configuration and customization.
• Instrument and system integration (e.g., chromatography, spectroscopy, sequencing).
• Validation and compliance documentation.
• Laboratory process optimization.
• SOP development and user training.
• Regulatory compliance with FDA, GLP, GMP, GAMP 5, ISO 17025.
• Strong communication and stakeholder management skills.
• Proven ability to manage multiple projects and collaborate with global teams.

• Experience bridging technical and business teams to deliver optimized solutions.
• Familiarity with global regulatory frameworks and audit practices.

• Certifications in LIMS administration, Computer System Validation (CSV), GAMP 5, or Quality/Regulatory Compliance are highly desirable.