CSV Validation Lead

Job Description:

DXC Technology (NYSE: DXC) helps global companies run their mission-critical systems and operations while modernizing IT, optimizing data architectures, and ensuring security and scalability across public, private, and hybrid clouds. The world’s largest companies and public sector organizations trust DXC to deploy services across the Enterprise Technology Stack to drive new performance levels, competitiveness, and customer experience. Learn more about how we deliver excellence for our customers and colleagues at DXC.com.

CSV Validation Lead

The CSV Validation Lead is responsible for overseeing the lifecycle validation of computer systems to ensure compliance with global regulatory standards (e.g., FDA 21 CFR Part 11, EU Annex 11). This role provides strategic leadership in developing validation frameworks, managing risk-based testing strategies, and ensuring that all IT systems—from lab equipment to enterprise ERPs—are fit for their intended use and maintain data integrity.

Requirements

• GxP Mastery: Expert knowledge of FDA 21 CFR Part 11, EU Annex 11, and GAMP 5 guidelines.

• Experience: 7+ years in CSV, with at least 2 years in a leadership or coordination capacity within a regulated industry.

• System Knowledge: Experience validating platforms such as SAP S/4HANA, LIMS, QMS (TrackWise/Veeva), MES, or clinical trial systems.

• Cloud Compliance: Understanding of validating SaaS/Cloud solutions and managing the shared responsibility model

• Attention to Detail: An uncompromising eye for documentation quality and "audit-ready" evidence.

• Risk Management: Ability to apply ICH Q9 principles to scale validation efforts effectively (don't over-validate low-risk items).

• Communication: Ability to negotiate between IT (who want speed) and QA (who want compliance).

Key Responsibilities

• Validation Strategy: Develop and maintain the Validation Master Plan (VMP). Define the scope of validation efforts using a risk-based approach (GAMP 5).

• Lifecycle Documentation: Lead the creation, review, and approval of core validation deliverables, including:

• User Requirements Specifications (URS)

• Risk Assessments (RA)

• Functional/Configuration Specifications

• Validation Plans & Summary Reports

• Testing Oversight: Manage the execution of IQ, OQ, and PQ (Installation, Operational, and Performance Qualification). Ensure deviations are documented, investigated, and closed correctly.

• Data Integrity: Act as the subject matter expert (SME) for ALCOA+ principles, ensuring systems are designed to maintain electronic record integrity.

• Audit & Inspection Support: Represent the CSV function during internal audits and external regulatory inspections (e.g., FDA, EMA). Defend validation packages to auditors.

• Vendor Management: Perform technical audits of software vendors and SaaS providers to ensure their SDLC processes meet GxP requirements.

• Change Control: Review and approve system changes to ensure the validated status is maintained throughout the system's life.

Basic Qualifications

• Bachelor’s degree in Life Sciences, Engineering, Computer Science, or a related technical field.

• Relevant certifications (e.g., CISA, CSQE, or specific GAMP 5 training) are a significant plus.

Physical Requirements / Work Environment

• Project location Budapest - Hybrid

• Ability to participate in virtual meetings across multiple time zones.

#LI-hybrid

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