To independently lead the end-to-end implementation, configuration, validation, integration, deployment, and ongoing optimization of the Laboratory Information Management System (LIMS) for R&D, analytical, QC, and testing laboratory operations.
The role will act as the primary point of contact between laboratory users, QA/validation, IT, LIMS vendors, instrument vendors, and management.
Role: LIMS Implementation Lead
Key Responsibilities:
- Own end-to-end LIMS implementation for R&D/testing laboratories.
- Gather requirements and map laboratory workflows.
- Configure LIMS: samples, tests, methods, specifications, results, approvals, COA, stability, OOS/OOT, etc.
- Manage master data and data migration.
- Coordinate instrument, ERP, ELN/CDS and other system integrations.
- Lead UAT, validation, testing, go-live, and post-go-live support.
- Prepare/review URS, functional specifications, SOPs, test scripts, and validation documents.
- Train laboratory users and provide ongoing support.
- Coordinate LIMS vendors and manage implementation timelines/issues.
- Ensure compliance with applicable GxP, 21 CFR Part 11, GAMP 5, ALCOA+, and ISO 17025 requirements.
- Identify opportunities for laboratory automation and process improvement.
Must-Have Skills:
LIMS configuration, laboratory workflow knowledge, SQL, integrations/API, data migration, validation/CSV, project management, vendor management, and strong R&D/testing laboratory understanding.
Qualifications
- Bachelor's degree in computer science or related field from reputed university.
- Master's degree in computer science
- Proven experience in managing implementation of LIMS projects.
- Professional experience in Research & Development or Analytical Laboratory domains is preferred.
- Oracle ERP Cloud Certification or similar certification preferred.
Experience: 5–10 years
* The role will be responsible for end-to-end management and implementation of all digital transformation projects, ensuring seamless integration between the various functions, and supporting analytical and research operations through effective digital data management