Overview
Skills
Job Details
At NTT DATA, we know that with the right people on board, anything is possible. The quality, integrity, and commitment of our employees have been key factors in our company's growth and market presence. By hiring the best people and helping them grow both professionally and personally, we ensure a bright future for NTT DATA and for the people who work here.
For more than 25 years, NTT DATA Services have focused on impacting the core of your business operations with industry-leading outsourcing services and automation. With our industry-specific platforms, we deliver continuous value addition, and innovation that will improve your business outcomes. Outsourcing is not just a method of gaining a one-time cost advantage, but an effective strategy for gaining and maintaining competitive advantages when executed as part of an overall sourcing strategy.
NTT DATA's Client is 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 to join their team in Highland Heights, KY. 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.
About NTT DATA Services:
NTT DATA Services is a recognized leader in IT and business services, including cloud, data and applications, headquartered in Texas. As part of NTT DATA, a $30 billion trusted global innovator with a combined global reach of over 80 countries, we help clients transform through business and technology consulting, industry and digital solutions, applications development and management, managed edge-to-cloud infrastructure services, BPO, systems integration and global data centers. We are committed to our clients' long-term success. Visit nttdata.com or LinkedIn to learn more.
NTT DATA Services is an equal opportunity employer and considers all applicants without regarding to race, color, religion, citizenship, national origin, ancestry, age, sex, sexual orientation, gender identity, genetic information, physical or mental disability, veteran or marital status, or any other characteristic protected by law. We are committed to creating a diverse and inclusive environment for all employees. If you need assistance or an accommodation due to a disability, please inform your recruiter so that we may connect you with the appropriate team.
Where required by law, NTT DATA provides a reasonable range of compensation for specific roles. The starting hourly range for this remote role is ($40-46 hourly ). This range reflects the minimum and maximum target compensation for the position across all US locations. Actual compensation will depend on several factors, including the candidate's actual work location, relevant experience, technical skills, and other qualifications.
This position is eligible for company benefits that will depend on the nature of the role offered. Company benefits may include medical, dental, and vision insurance, flexible spending or health savings account, life, and AD&D insurance, short-and long-term disability coverage, paid time off, employee assistance, participation in a 401k program with company match, and additional voluntary or legally required benefits.