Opportunity for a Senior Consultant in Business Consulting Risk, specializing in Digital Risk within the TMT sector. EY Consulting is dedicated to transforming businesses through people, technology, and innovation, solving strategic problems to drive long-term client value. This role is part of a client-centric team focused on helping organizations navigate industry convergence, enhance competitiveness, and achieve agile strategies for growth.

We empower TMT companies to create exceptional employee and customer experiences, retain talent, and achieve operational excellence. Our work also involves safeguarding data, brands, and reputations, while enabling M&A strategies that build value and transform businesses into future leaders.

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 create and review essential CSV deliverables such as user requirements, system specifications, Validation Plans, Qualification Plans, SOPs, IQ/OQ/PQ, Traceability Matrix, Design Specs, and validation summary reports.

Provide guidance and oversight for validation activities on projects involving GxP relevant computer systems. Collaborate closely with project team members to integrate quality and compliance into the system lifecycle. Review and approve computer system validation work products, ensuring thorough planning and timely completion of deliverables.

To excel in this role, you should possess hands-on experience in Computer System Validation (CSV) for Enterprise Applications like LIMS, ERPs, LMS, RPA, and CTMS. Experience within an FDA-regulated environment with a strong understanding of cGxP (cGMP, cGDP, cGAMP, cGLP) standards and risk-based validation is essential.

A Bachelor of Technology in Computer Science is required. Experience with validation/testing tools such as HP ALM or Azure DevOps (ADO), and experience in training validation resources, will be considered advantageous. Candidates should demonstrate the ability to work collaboratively across departments, possess a practical problem-solving approach, and exhibit agility, curiosity, and creativity.