CSV Consultant

CSV Consultant - 12+ months contract - France

We are seeking a highly skilled CSV (Computer System Validation) Consultant to join our team and support our SAP ECC to S/4 HANA conversion. This role will be part of the delivery team and will focus on ensuring compliance with validation requirements throughout the project lifecycle. The ideal candidate will have a strong background in SAP validation and fluency in English.

Key Responsibilities:

• Develop and implement the validation strategy and plan, considering vendor quality assessment results and generating necessary validation deliverables.
• Supervise validation activities and maintain strong collaboration with the program testing lead to ensure alignment.
• Coordinate and complete system criticality assessments and business impact assessments, ensuring compliance with security, business continuity, data privacy, and GxP requirements.
• Participate in system risk analysis, providing expertise on system design, functions, data, interfaces, and infrastructure.
• Oversee the creation or updates of system-related specifications, including technical specifications and migration specifications.
• Ensure the development of system integration testing documentation and support related validation efforts.
• Ensure all traceability matrices, technical SOPs, instructions, and non-conformities are properly documented and implemented.
• Maintain and update the non-conformity log, working closely with the test lead.
• Provide CSV expertise and guidance on all validation topics, ensuring compliance with industry regulations and best practices.

Qualifications & Experience:

• 5 years of experience in Computer System Validation (CSV).
• Expertise in SAP validation within regulated industries (e.g., pharmaceuticals, life sciences, or manufacturing).
• Strong understanding of GxP, data integrity, and compliance frameworks.
• Experience with SAP ECC to S/4 HANA migration (brownfield approach preferred).
• Proficiency in English (spoken and written) is required.
• Excellent analytical, documentation, and communication skills.
• Ability to work collaboratively within a fast-paced, cross-functional team.

Preferred Qualifications:

• Experience with CSV frameworks such as GAMP 5.
• Knowledge of regulatory requirements (FDA, EMA, ISO, etc.) related to SAP validation.
• Previous involvement in large-scale SAP implementations or migrations.