Embark on a career in Business Consulting focused on Risk within the Technology, Media, and Telecommunications (TMT) sector. This role involves navigating the dynamic landscape of industry convergence, helping TMT organizations transform and achieve agile growth strategies. You will contribute to enhancing employee and customer experiences, safeguarding data and brand reputation, and enabling M&A strategies that drive value and reduce risk.

As part of EY Consulting, you will be instrumental in building a better working world through innovation and technology. Our client-centric approach tackles strategic challenges, focusing on long-term value creation. This position is within the CNS - RISK - DIGITAL RISK team, emphasizing the interplay between upside and downside risk to inform strategic decisions and protect organizational objectives.

Key responsibilities include performing Computer System Validation (CSV) assessments for Life Sciences clients, ensuring compliance with internal procedures, best practices, and regulatory requirements. You will develop and review crucial CSV documentation such as 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 teams to integrate quality and compliance into the system lifecycle. You will also review and approve computer system validation work products, ensuring thoroughness in planning and timely delivery of validation outcomes.

To excel in this role, you need a Bachelor of Technology in Computer Science, Bachelor of Pharmacy, or a Bachelor of Computer Applications degree. The position requires 2 to 13 years of hands-on experience in Computer System Validation (CSV), particularly with Enterprise Applications like LIMS, ERPs, LMS, RPA, or CTMS.

Demonstrated experience within an FDA-regulated environment is essential, coupled with a strong understanding of cGxP (cGMP, cGDP, cGAMP, cGLP) standards and risk-based validation methodologies. Possessing experience with validation/testing tools such as HPALM or Azure DevOps (ADO) would be a significant advantage, as would experience in training validation resources. We seek individuals who can collaborate effectively, solve complex problems with practical solutions, and demonstrate agility, curiosity, and creativity.