Join our dynamic Business Consulting Risk team as a Senior Consultant, focusing on the Technology, Media, and Telecommunications (TMT) sector. This role is crucial in helping TMT organizations navigate industry convergence, overcome competitiveness challenges, and develop agile strategies for growth. We empower clients to create exceptional customer and employee experiences, achieve operational excellence, and safeguard their data, brand, and reputation.

As part of EY Consulting, you will contribute to transforming businesses through innovation and technology. Our client-centric approach is dedicated to solving complex strategic problems and driving long-term value. You'll be instrumental in helping clients identify and manage risks, ensuring their ability to meet future business objectives and objectives.

Your primary responsibilities will involve performing assessments of computer systems and processes for Life Sciences clients, ensuring compliance with internal procedures, leading practices, and regulatory requirements. You will also create and review critical Computer System Validation (CSV) deliverables, including validation plans, qualification plans, SOPs, IQ/OQ/PQ reports, 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 thoroughness and timely completion of all deliverables.

To excel in this role, you need a Bachelor of Technology in Computer Science and 2 to 13 years of hands-on experience in Computer System Validation (CSV). You should possess a strong understanding of Quality and Compliance within the context of Enterprise Applications such as LIMS, ERPs, LMS, RPA, and CTMS.

Demonstrated experience in FDA-regulated environments with a solid grasp of cGxP standards (cGMP, cGDP, cGAMP, cGLP) and risk-based validation is essential. Experience with validation/testing tools like HPALM or Azure DevOps (ADO) is advantageous. We seek individuals with a collaborative spirit, a practical approach to problem-solving, and the ability to deliver insightful solutions. Agility, curiosity, mindfulness, and adaptability are key attributes for success in this role.