Join our dynamic Business Consulting Risk team as a Senior Consultant, specializing in Digital Risk within the Technology, Media, and Telecommunications (TMT) sector. EY Consulting is dedicated to transforming businesses through innovation and technology, helping clients navigate industry convergence and achieve agile growth strategies.

We empower TMT companies to enhance customer experiences, retain talent, and achieve operational excellence. Our focus is on safeguarding data, brand reputation, and enabling strategic M&A activities that drive value and reduce risk. We are committed to building a better working world for all.

As a Senior Consultant, your key responsibilities will involve performing assessments of computer systems and processes for Life Sciences clients, ensuring compliance with internal procedures, leading practices, and regulatory requirements. You will create and review critical CSV deliverables, including validation plans, IQ/OQ/PQ, and summary reports.

Provide expert guidance and oversight for validation activities on GxP-relevant computer systems. Collaborate closely with project teams to integrate quality and compliance throughout the system lifecycle and review/approve validation work products, ensuring timely completion of deliverables.

To excel in this role, you should possess hands-on experience in Computer System Validation (CSV) with Enterprise Applications (LIMS, ERPs, LMS, RPA, CTMS). A strong understanding of the FDA regulated environment, cGxP standards (cGMP, cGDP, cGAMP, cGLP), and risk-based validation is essential.

Experience with validation/testing tools such as HPALM or Azure DevOps (ADO) is a significant advantage. We are looking for individuals with 2 to 13 years of relevant experience who demonstrate a collaborative approach, possess practical problem-solving skills, and exhibit agility, curiosity, and creativity.