Join a global leader in assurance, tax, transaction, and advisory services committed to building a better working world. We foster a culture of continuous learning and development, offering unparalleled opportunities for professional growth and creative freedom. At EY, we invest in your potential, helping you become your best professional self through motivating and fulfilling career experiences. This role is focused on Digital Risk within the Business Consulting segment, serving the Consumer Products and Health Sciences & Wellness sectors.

Our Consulting practice drives transformative change through people, technology, and innovation. We focus on solving our clients' most strategic problems with a client-centric approach to deliver long-term value. Within EY Consulting, we specialize in Business Consulting (including Performance Improvement and Risk Consulting), Technology Consulting, and People Advisory Services.

Your primary responsibilities will involve ensuring technical excellence in computer system validation (CSV) throughout the system lifecycle. This includes managing requirements, risk assessments, testing, and creating comprehensive validation documentation.

You will need a solid understanding of 21 CFR Part 11 requirements, covering electronic records, electronic signatures, audit trails, access controls, and data integrity. The role requires proficiency in preparing and executing validation deliverables such as validation plans, URS, FRS, IQ/OQ/PQ protocols, and traceability matrices.

Familiarity with GxP-regulated computerized systems and their compliance expectations during regulatory inspections and audits is essential. You will be responsible for identifying gaps in system controls and proposing remediation strategies that align with current regulatory and industry standards.

To qualify for this role, you must possess a Bachelor of Technology in Computer Science and have a minimum of 3 years of experience in Quality Assurance & Testing.

We are seeking individuals with the ability to collaborate effectively across multiple client departments while adhering to commercial and legal requirements. A practical approach to problem-solving, delivering insightful and actionable solutions is crucial.

Ideal candidates will be agile, curious, mindful, and capable of maintaining positive energy. Adaptability and creativity in your approach to challenges will set you apart. We offer a personalized career journey with access to resources that illuminate roles, skills, and future opportunities.