Join our dynamic Business Consulting Risk team, specializing in the Technology, Media, and Telecommunications (TMT) sector. We partner with TMT organizations to navigate industry convergence, enhance competitiveness, and drive agile strategies for sustainable growth. Our focus is on creating exceptional employee and customer experiences, safeguarding data and brand reputation, and enabling value-generating M&A strategies.

As part of EY Consulting, you'll contribute to transforming businesses through people, technology, and innovation. We assist clients in identifying and managing risks to protect their future business strategy and objectives. Our expertise spans Enterprise Risk, Technology Risk, and Financial Services Risk, addressing critical areas like resilience, internal audit, compliance, and technology risk assessment.

Key responsibilities include performing Computer System Validation (CSV) assessments for Life Sciences clients, ensuring compliance with procedures, best practices, and regulatory requirements. You will create and review critical CSV deliverables such as validation plans, specifications, IQ/OQ/PQ, and summary reports. Provide expert guidance on validation activities for GxP-relevant systems and collaborate closely with project teams to integrate quality and compliance throughout the system lifecycle. Review and approve validation work products, ensuring thoroughness and timely completion of deliverables.

To excel in this role, you must possess 2 to 13 years of hands-on experience in Computer System Validation (CSV), particularly with Enterprise Applications like LIMS, ERPs, LMS, RPA, and CTMS. Experience within an FDA-regulated environment, coupled with a strong understanding of cGxP (cGMP, cGDP, cGAMP, cGLP) standards and risk-based validation principles, is essential. A Bachelor of Technology in Computer Science, Bachelor of Computer Applications, or B.Pharmacy is required. Experience with validation/testing tools like HP ALM or Azure DevOps (ADO) is a significant advantage, as is experience in training validation resources. We seek adaptable, curious, and creative individuals with a practical approach to problem-solving and a collaborative spirit.