CSV Engineer

About KKR Consulting KKR Consulting partners with leading pharmaceutical and life science organizations to deliver expert consulting, engineering, and quality solutions. Our teams specialize in driving compliance, digital transformation, and data integrity across global GxP environments ensuring innovation with regulatory excellence. Role Overview We are seeking a CSV Engineer (CSV Analyst) to support the implementation of Computer System Validation (CSV) and Data Integrity (DI) strategies at our client’s Concord, NC site. The role will work closely with site and global leaders to embed CSV and Data Integrity principles into daily operations ensuring compliance, consistency, and sustainability for all local and global systems. This position offers an opportunity to influence technology governance and strengthen CSV/DI frameworks that align with corporate quality and regulatory objectives. Exp: 5+ Years Key Responsibilities • Implement and sustain CSV and Data Integrity strategies in alignment with global and local regulatory standards. • Partner with site leaders and SMEs to assess and validate new and existing systems from a Data Integrity perspective. • Lead technology improvement projects enhancing DI/CSV compliance and governance. • Collaborate cross-functionally to establish best practices, perform gap analyses, and drive remediation for policies, SOPs, and quality systems. • Support and represent the site during audits, deviations, and CAPA investigations related to DI/CSV. • Ensure consistent and systematic approaches to DI/CSV expectations, including audit trail review, workstation security, and standalone equipment integration. • Protect information assets and ensure compliance with corporate cybersecurity and access control standards. Qualifications • Bachelor’s degree in Software Engineering, Computer Science, Computer Engineering, or related discipline. • 5+ years of experience in a GMP-regulated environment with a strong understanding of IT quality and compliance processes. • Proven expertise in Computer System Validation (21 CFR Part 11, Annex 11) and Data Integrity principles. • Strong problem-solving, analytical, and communication skills with the ability to influence cross-functional teams. • Adaptability to work in a fast-paced, highly regulated manufacturing or lab setting. Preferred Qualifications • Master’s degree in Software Engineering, Computer Science, or a related field. • Experience in Agile-based solution development for validation, automation, or modernization projects. • Exposure to global operations and cross-functional technical collaboration. • Demonstrated leadership in mentoring and developing technical teams.