Join our dynamic Business Consulting Risk team focused on the Technology, Media, and Telecommunications (TMT) sector. We empower TMT organizations to navigate industry convergence, drive agile strategies, and achieve sustainable growth. You'll play a key role in helping clients protect their data, brand, and reputation while pursuing value-creating M&A opportunities. This is your chance to contribute to building a better working world.

Our EY Consulting practice is dedicated to transforming businesses through innovation and technology. We focus on solving our clients' most strategic problems by understanding the interplay between potential risks and rewards. Within EY Consulting, you'll be part of a team that helps clients build agility and resilience in enterprise risk management, technology risk, and financial services risk.

This role offers a unique opportunity to work on critical digital risk initiatives. We are seeking talented individuals to join us in shaping the future of technology risk and compliance. Be part of a collaborative environment where your contributions are valued and your career development is a priority.

Perform comprehensive assessments of computer systems and processes for Life Sciences clients, ensuring compliance with internal procedures, leading practices, and regulatory mandates. Create and review crucial 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 embed quality and compliance throughout the system lifecycle. Review and approve computer system validation work products, ensuring the thoroughness of planning and timely completion of deliverables.

We are seeking candidates with 2 to 13 years of experience in Computer System Validation (CSV) and IT Risk Assessment (ITRA). Demonstrated experience with Enterprise Applications such as LIMS, ERPs, LMS, RPA, and CTMS is essential. A strong understanding of the FDA regulated environment and cGxP (cGMP, cGDP, cGAMP, cGLP) standards, along with risk-based validation methodologies, is required. Possession of a Bachelor of Technology in Computer Science, B.Pharmacy, or Bachelor of Computer Applications is necessary. Experience with validation/testing tools like HP ALM or Azure DevOps (ADO) is considered an advantage. Experience in training validation resources is also a plus.