RC-REGULATORY COMPLIANCE-Lab Digitisation - CA-Labware-Senior
EY
EY
Join EY's Regulatory Compliance team as a Senior LIMS Configuration Analyst and drive innovative solutions in the life sciences sector. This role offers a unique opportunity to enhance your career within a leading global firm, contributing to the growth of our specialized service offerings. You'll play a pivotal role in implementing and customizing Laboratory Information Management Systems (LIMS) to meet stringent regulatory requirements and improve laboratory operations.
Collaborate with stakeholders to gather and analyze LIMS requirements, configuring platforms like LabWare, Benchling, and STARLIMS to support end-to-end laboratory workflows. Design and implement master data, workflows, and business rules aligned with GxP and regulatory standards. Develop integrations with enterprise systems, support validation activities (IQ/OQ/PQ), and troubleshoot system performance. Ensure data integrity, traceability, and compliance with GxP, 21 CFR Part 11, and Annex 11. Identify opportunities for automation and process improvement within laboratory operations.
We are seeking a Senior professional with 5-8 years of experience in LIMS implementations and configurations for life sciences industries. A Bachelor's degree in Computer Science, Life Sciences, Chemistry, Information Technology, or a related field, or a Postgraduate degree in Science (preferably Chemistry/Biochemistry) is required. Essential skills include strong knowledge of laboratory workflows, data integrity principles, LIMS software proficiency (LabWare, LabVantage, STARLIMS), system integration, validation, and troubleshooting. Excellent communication, analytical skills, and the ability to work both independently and within a team are crucial.
EY Global Delivery Services ( EY GDS)
Information Technology & Services