Subject Matter Expert (LIMS/CSV)

Role Description

The LIMS SME is responsible for leading the design, development, and implementation of Laboratory Information Management System (LIMS) solutions. This role also involves actively supporting the promotion of LIMS products through product demonstrations and participation in pre-sales activities. Close collaboration with laboratory teams, IT personnel, business stakeholders, and clients is essential to ensure the LIMS software effectively supports lab operations, complies with regulatory standards, and aligns with evolving market requirements.

Job Location

Pan India (Hybrid/Remote)

Responsibilities

● Lead the end-to-end implementation of Laboratory Information Management Systems (LIMS), including requirements analysis, system configuration, integration, and deployment

● Design scalable and compliant LIMS solutions tailored to client-specific workflows, regulatory requirements, and industry best practices

● Oversee system architecture planning, data migration, and instrument integration with laboratory instruments and external systems (e.g., ERP, ELN, CDS).

● Conduct in-depth business analysis and gather functional and technical requirements through customer workshops and documentation reviews

● Translate business needs into detailed functional specifications and validate them with stakeholders for approval

● Act as the primary liaison between laboratory users, IT teams, QA/RA throughout the project lifecycle

● Lead and manage Computer System Validation (CSV) activities for LIMS in accordance with GAMP 5 and regulatory standards like 21 CFR Part 11, Annex 11, and GxP

● Prepare and review validation documents including URS, FS, IQ, OQ, PQ, Traceability Matrix, and Risk Assessments (e.g., FMEA)

● Ensure LIMS configurations and changes maintain data integrity (ALCOA+) and audit-readiness

● Provide subject matter expertise on laboratory operations, including sample management, test workflows, results review, inventory, stability studies, QA/QC, and reporting

● Apply domain knowledge across industries such as Pharmaceuticals, Life Sciences, Clinical Research, Diagnostics, and Manufacturing.

● Serve as a functional lead on customer projects, guiding cross-functional teams and ensuring successful delivery of LIMS solutions

● Establish and maintain strong client relationships through regular communication, issue resolution, and continuous support

● Drive change management, UAT coordination, go-live planning, and post-implementation support

● Participate in pre-sales efforts including product demonstrations, solution design during RFP responses, and functional requirement mapping

● Develop and deliver training programs for end users and administrators to ensure system adoption and proficiency

● Stay updated on emerging technologies and regulatory trends impacting laboratory informatics and digital transformation

Skills:

● Hands-on experience with LIMS platforms (e.g., LabWare, LabVantage, StarLIMS Caliber, etc.)

● Configuration and customization of workflows, sample management, and instrument integration

● SQL for querying and troubleshooting database issues.

● Familiarity with relational databases (e.g., Oracle, MS SQL Server)

● Understanding of system architecture, servers, and cloud/on-prem deployments.

● Knowledge of integrating LIMS with instruments

● Understanding of GxP, 21 CFR Part 11, ISO 17025, and data integrity (ALCOA+)

● Involvement in CSV (Computer System Validation) and IQ/OQ/PQ documentation

● Strong analytical mindset to resolve configuration, workflow, or integration issues

● Ability to translate lab or business needs to technical teams and vice versa

Qualifications

● A Bachelor’s degree in Information Technology, Computer Science, Pharmaceutical Sciences, or a related field is required; a Master’s degree is preferred

● Minimum of 10 years’ experience working with LIMS software, including implementation, support, and customization

● Proven experience in pre-sales activities and delivering product demonstrations to prospective clients

● In-depth understanding of laboratory operations, workflows, and procedures across various scientific domains

● Strong familiarity with applicable regulatory requirements and industry standards (e.g., GxP, 21 CFR Part 11, ISO 17025)

● Demonstrated leadership abilities and experience managing cross-functional teams

● Excellent analytical and problem-solving skills, with a focus on delivering practical and compliant solutions

● Outstanding verbal and written communication skills, with the ability to clearly articulate concepts and confidently present software capabilities

#LIMS #LIMSJobs #LaboratoryInformatics #ComputerSystemValidation #CSV