EY Consulting is dedicated to building a better working world through the power of people, technology, and innovation. Our client-centric approach drives long-term value by solving strategic problems for businesses. Within EY Consulting, we focus on Business Consulting, Technology Consulting, and People Advisory Services. We assist TMT (Technology, Media & Entertainment, and Telecommunications) organizations in navigating industry convergence, fostering transformation, and achieving agile strategies for growth. We help create compelling employee and customer experiences, retain talent, and drive operational excellence while protecting data, brand, and reputation. We also support M&A strategies to create value, reduce risk, and position TMT companies as leaders in the future technology revolution.

Our CNS - RISK - DIGITAL RISK service line helps clients identify and manage the interplay between risk and opportunity, enabling informed decisions to protect their future business strategy and objectives. This includes focusing on Enterprise Risk, Technology Risk, and Financial Services Risk. We equip clients with the agility to respond quickly to key risk areas and ensure trusted communications on internal control and regulatory compliance.

As a Consultant in Digital Risk, you will be instrumental in assessing computer systems and processes for Life Sciences clients, ensuring compliance with internal procedures, industry best practices, and regulatory requirements. You will be responsible for creating and reviewing critical Computer System Validation (CSV) deliverables, including user requirements, system specifications, Validation Plans, Qualification Plans, SOPs, IQ/OQ/PQ, Traceability Matrices, Design Specifications, and validation summary reports.

Your role will involve providing expert guidance and oversight for validation activities on projects involving GxP-relevant computer systems. You will collaborate closely with project team members to embed quality and compliance throughout the system lifecycle. Furthermore, you will review and approve computer system validation work products, ensuring thoroughness in planning and timely delivery of all validation documentation.

To excel in this role, you should possess 2 to 13 years of hands-on experience in Computer System Validation (CSV) within a Quality and Compliance framework. Experience with enterprise applications such as LIMS, ERPs, LMS, RPA, and CTMS is essential. A strong understanding of FDA-regulated environments and cGxP (cGMP, cGDP, cGAMP, cGLP) standards, along with experience in risk-based validation, is required.

Possessing experience with validation and testing tools like HPALM or Azure DevOps (ADO) will be a significant advantage. Additionally, experience in training validation resources is highly desirable. Educational qualifications include a Bachelor of Technology in Computer Science, a B. Pharmacy, or a Bachelor of Computer Applications. We seek individuals who can collaborate effectively, offer practical solutions to complex problems, and demonstrate agility, curiosity, and creativity.