Join EY's Business Consulting team as a Senior Consultant, specializing in Risk and Digital Risk within the Technology, Media, and Telecommunications (TMT) sector. This role offers an exciting opportunity to help TMT organizations navigate industry convergence, enhance competitiveness, and drive agile strategies for growth. You'll contribute to creating exceptional employee and customer experiences, protecting data and brand reputation, and enabling M&A strategies that build value and reduce risk.

EY Consulting is dedicated to building a better working world through innovation and technology. We focus on solving our clients' most strategic problems by identifying and managing risks, enabling them to meet their future business objectives. Our expertise spans Enterprise Risk, Technology Risk, and Financial Services Risk.

As a Senior Consultant, you will play a key role in Computer System Validation (CSV) within our Digital Risk practice. Your responsibilities will include:

- Conducting assessments of computer systems and processes for Life Sciences clients, ensuring compliance with internal procedures, leading practices, and regulatory requirements. - Developing and reviewing critical CSV deliverables such as user requirements, system specifications, Validation Plans, Qualification Plans, SOPs, IQ/OQ/PQ, Traceability Matrix, Design Specifications, and validation summary reports. - Providing expert guidance and oversight for validation activities on projects involving GxP-relevant computer systems. - Collaborating closely with project team members to embed quality and compliance throughout the system lifecycle. - Reviewing and approving computer system validation work products, ensuring thoroughness and timely completion of deliverables.

To excel in this role, you should possess:

- A Bachelor of Technology degree in Computer Science or Pharmacy. - 2 to 13 years of hands-on experience in Computer System Validation (CSV), with a strong understanding of Enterprise Applications like LIMS, ERPs, LMS, RPA, and CTMS. - Proven experience within an FDA-regulated environment, demonstrating a solid grasp of cGxP (cGMP, cGDP, cGAMP, cGLP) standards and risk-based validation principles. - Experience working collaboratively to deliver services across multiple client departments while adhering to commercial and legal requirements. - A practical, insightful, and agile approach to problem-solving complex issues. - Adaptability, creativity, and a positive, mindful attitude are highly valued.