Join EY's global team to build a unique career in Regulatory Compliance, focusing on LIMS implementations for the Life Sciences sector. This role offers an exceptional opportunity to contribute to a leading firm's growth in emerging service areas, leveraging your expertise to deliver high-quality solutions and drive operational excellence.

As a key member of our Regulatory Compliance team, you will be instrumental in understanding client needs and providing tailored LIMS configuration and implementation services. You'll collaborate closely with stakeholders, laboratory personnel, and IT teams to ensure seamless integration of laboratory workflows and compliance with stringent regulatory standards.

Configure and customize LIMS platforms (LabWare, Benchling, STARLIMS) to support end-to-end laboratory operations, including sample management, testing, and reporting. Design and implement master data, workflows, and business rules aligned with GxP requirements and regulatory standards. Develop integrations between LIMS and enterprise systems like ERP, MES, and ELN using APIs. Support validation activities by preparing documentation and executing IQ/OQ/PQ, ensuring adherence to 21 CFR Part 11 and ALCOA+ principles. Troubleshoot and optimize system performance, driving continuous improvement in laboratory operations.

Analyze technical documents and convert them into LIMS-compatible data sets. Configure master data elements such as test methods, sample types, and specifications. Ensure data integrity, consistency, and version control. Develop, customize, and implement LIMS applications, providing technical support and bug fixes. Collaborate with teams to enhance system functionality and usability, ensuring compliance with CGxP, PICS, FDA 21 CFR Part 11, and EU GMP Annex 11.

Candidates should possess a B.E/B.Tech in Computer Science, Life Sciences, Chemistry, or Information Technology, or a Postgraduate degree in Science (preferably Chemistry/Biochemistry), coupled with 5-8 years of experience in regulatory compliance within Big 4 or multinational companies, or leading life sciences/pharmaceutical industries.

Essential skills include a strong understanding of laboratory workflows, data integrity principles, and familiarity with analytical techniques, laboratory instrumentation, and regulatory standards like GLP, GMP, and ISO 17025. Proficiency in LIMS software (e.g., LabWare, LabVantage, STARLIMS) and knowledge of system integration with enterprise applications are crucial. Excellent problem-solving, analytical, and communication abilities are vital for stakeholder management and effective teamwork.