Join our dynamic Business Consulting Risk team, specializing in the TMT sector and Digital Risk. We empower Technology, Media, and Telecommunications organizations to navigate industry convergence, drive transformation, and achieve agile growth strategies. Our focus is on creating exceptional employee and customer experiences, safeguarding data and brand reputation, and enabling M&A strategies that foster innovation and value creation.

As part of EY Consulting, you'll contribute to building a better working world by transforming businesses through people, technology, and innovation. We tackle complex strategic challenges and focus on driving long-term value for our clients. Our work within CNS - RISK - DIGITAL RISK helps organizations identify and manage risks, ensuring they can meet future business objectives.

As a Consultant in Digital Risk, your responsibilities will include: - Performing assessments of computer systems and processes for Life Sciences clients, ensuring compliance with internal procedures, best practices, and regulatory mandates. - Creating and reviewing essential Computer System Validation (CSV) deliverables, such as user requirements, validation plans, IQ/OQ/PQ, and summary reports. - Providing expert guidance and oversight for validation activities on projects involving GxP-relevant computer systems. - Collaborating closely with project teams to embed quality and compliance throughout the system lifecycle. - Reviewing and approving computer system validation work products, ensuring thorough planning and timely completion of deliverables.

To excel in this role, you should possess: - 2 to 13 years of experience in Computer System Validation (CSV). - Hands-on experience with computer system validation for Enterprise Applications like LIMS, ERPs, LMS, RPA, and CTMS. - Familiarity with FDA-regulated environments and a strong understanding of cGxP (cGMP, cGDP, cGAMP, cGLP) standards, coupled with risk-based validation approaches. - A Bachelor of Technology in Computer Science, Bachelor of Pharmacy, or Bachelor of Computer Applications. - The ability to collaborate effectively across multiple client departments while adhering to commercial and legal requirements. - A practical, insightful, and creative approach to problem-solving, demonstrating agility and a positive mindset.