This Senior Consultant role within EY's Business Consulting Risk practice focuses on the Technology, Media & Entertainment, and Telecommunications (TMT) sector. You will be instrumental in helping TMT organizations navigate industry convergence, transform their operations, and develop agile strategies for growth. The focus is on creating exceptional employee and customer experiences, safeguarding data and brand reputation, and driving value through strategic M&A.

EY Consulting is dedicated to building a better working world by leveraging people, technology, and innovation. Our client-centric approach aims to solve strategic problems and deliver long-term value. The CNS - RISK - DIGITAL RISK team specializes in identifying and managing risks to ensure organizations can achieve their future business objectives. This includes expertise in Enterprise Risk, Technology Risk, and Financial Services Risk.

- Conduct assessments of computer systems and processes for Life Sciences clients, ensuring compliance with internal procedures, leading practices, and regulatory mandates. - Develop and review critical Computer System Validation (CSV) deliverables, including user requirements, system specifications, Validation Plans, Qualification Plans, SOPs, IQ/OQ/PQ, Traceability Matrix, Design Specs, and validation summary reports. - Provide expert guidance and oversight for validation activities on projects involving GxP-relevant computer systems. - Collaborate closely with project team members to integrate quality and compliance elements throughout the system lifecycle. - Review and approve computer system validation work products, ensuring the thoroughness of validation planning and timely completion of deliverables.

- Possess hands-on experience in computer system validation (CSV) for enterprise applications such as LIMS, ERPs, LMS, RPA, and CTMS. - Demonstrate a strong understanding of a FDA-regulated environment and cGxP (cGMP, cGDP, cGAMP, cGLP) standards, coupled with a risk-based validation approach. - Experience with validation/testing tools like HP ALM or Azure DevOps (ADO) is considered an advantage. - Prior experience in training validation resources is a plus. - A Bachelor of Technology in Computer Science is required.