This role offers an exciting opportunity for a Senior Consultant within EY's Business Consulting Risk practice, focusing on Digital Risk for Technology, Media, and Telecommunications (TMT) clients. You will play a crucial role in helping TMT organizations navigate industry convergence and transform their operations.

Our TMT practice supports companies in creating exceptional employee and customer experiences, optimizing operational excellence, and safeguarding data and brand reputation. We enable strategic M&A activities that drive value and position clients to lead future technology revolutions.

EY Consulting is dedicated to building a better working world through people, technology, and innovation. We tackle our clients' most strategic problems with a client-centric approach, driving long-term value. Our practice encompasses Business Consulting, Technology Consulting, and People Advisory Services.

Key responsibilities include performing Computer System Validation (CSV) assessments for Life Sciences clients, ensuring compliance with internal procedures, leading practices, and regulatory requirements. You will create and review essential CSV deliverables such as user requirements, system specifications, validation plans, and 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. Review and approve computer system validation work products, ensuring thorough planning and timely completion of deliverables.

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

Experience with validation/testing tools such as HPALM or Azure DevOps (ADO) would be advantageous, as would experience in training validation resources. We are seeking individuals with a Bachelor of Technology in Computer Science or Pharmacy and 2 to 13 years of relevant CSV experience. Candidates should demonstrate a practical, collaborative approach to problem-solving and a commitment to delivering insightful solutions.