CSV Analyst

Mantell Associates is looking for a CSV Analyst to join a high-impact SAP S/4 HANA transformation project in a compliance-driven role.

In this role, you’ll play a key part in ensuring that validation and compliance requirements are met throughout the project, aligning all systems and processes with internal quality standards and global regulatory guidelines.

CSV Analyst - Responsibilities:

• Ensure all validation activities within the SAP S/4 HANA program comply with regulatory and internal CSV standards
• Coordinate validation tasks and timelines in close collaboration with internal teams and third-party vendors
• Translate business and compliance needs into concrete validation deliverables
• Prepare and review validation documentation, including URS, FS, RTM, test strategies, test scripts, and summary reports
• Support internal and external audits by delivering complete, audit-ready validation records
• Provide regular updates on validation progress in project meetings and proactively raise potential risks or issues
• Contribute to the investigation and resolution of validation-related deviations, including root cause analysis and CAPA
• Promote a collaborative, quality-focused project culture through cross-functional engagement

CSV Analyst - Requirements:

• Minimum of 3 years' experience in SAP validation within regulated (GxP) environments
• Strong understanding of CSV frameworks and regulatory requirements (GxP, FDA, EMA, GAMP 5)
• Familiarity with pharmaceutical manufacturing processes and SAP QM (Quality Management) modules
• Demonstrated expertise in authoring and managing validation documentation across the system lifecycle
• Experience working in complex stakeholder environments, especially within matrix organizations
• Hands-on experience with SAP ECC and/or S/4 HANA, particularly in compliance contexts
• Ability to manage multiple tasks and priorities independently with strong organizational skills
• Fluent in English (written and spoken), with excellent communication and documentation skills
• Working knowledge of French and/or Dutch is a plus

Mantell Associates is a specialist Pharmaceutical and Life Science headhunting firm. For more information on this opportunity, contact us at +44 (0)20 3854 7700.