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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.

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.

Key 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.

Required Skills & Experience:

• 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.

Education:

• 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.

Workplace type:

Hybrid Working

About NTT DATA
NTT DATA is a $30+ billion trusted global innovator of business and technology services. We serve 75% of the Fortune Global 100 and are committed to helping clients innovate, optimize and transform for long-term success. We invest over $3.6 billion each year in R&D to help organizations and society move confidently and sustainably into the digital future. As a Global Top Employer, we have diverse experts in more than 50 countries and a robust partner ecosystem of established and start-up companies. Our services include business and technology consulting, data and artificial intelligence, industry solutions, as well as the development, implementation and management of applications, infrastructure, and connectivity. We are also one of the leading providers of digital and AI infrastructure in the world. NTT DATA is part of NTT Group and headquartered in Tokyo.

Equal Opportunity Employer
NTT DATA is proud to be an Equal Opportunity Employer with a global culture that embraces diversity. We are committed to providing an environment free of unfair discrimination and harassment. We do not discriminate based on age, race, colour, gender, sexual orientation, religion, nationality, disability, pregnancy, marital status, veteran status, or any other protected category. Join our growing global team and accelerate your career with us. Apply today.

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