SAP S/4 HANA CSV Consultant (m/w/d)

Tasks :

• Responsible for the validation of computerised systems (CSV), including managing change controls for SAP S/4 HANA and other regulated systems, platform/infrastructure and tool qualification.
• Develop appropriate validation and/or qualification approaches for various SAP S/4HANA system functionalities and modules (including GxP, SOX/JSOX, and non-regulated areas).
• Rollout of SAP S/4HANA in various regions and maintenance of global deployment, including change management.
• Guiding and advising project teams on compliance assessments, requirements, test scripts, validation plans/protocols and reports.
• Implementing CSV, QA and/or IT activities throughout the entire lifecycle, including initial implementation, modification and decommissioning.
• Deep understanding and expert advice for method validation, process validation, equipment validation and instrument QC/testing in production facilities to ensure GMP compliance
• Advising the audit team on communicating observations and recommendations, including assessing impacts and risk
• Provide qualified CSV advice during the rollout of global solutions/systems and ensure that global standards/SOPs are effective, regulatory compliant and implementable.
• Identification and implementation of strategic quality and business initiatives, including suitable remediation programmes, quality/compliance activities and relevant changes.

Qualification:

• Bachelor’s degree in scientific or engineering discipline along with 10+ years of experience in the field of computer validation in the Life Sciences (Pharmaceutical, Medical Devices) and Healthcare industries is desirable.
• 10+ years’ experience in GxP / QA within FDA/EMA regulated environments GAMP 5 with risk-based CSV is required.
• Must have extensive experience in validation and qualification of SAP S/4 HANA.
• Experience in developing full validation documentation and testing protocols (IQ/OQ/PQ/UAT) within the various SDLC phases.
• Ability to communicate effectively at all levels in the company in English.
• Exceptional attention to detail, cross-checking, and verifying correctness of data.
• Ability to effectively manage time to meet assigned deadlines and prioritize multiple work assignments.
• Ability to work independently with minimal supervision.
• Excellent Technical Writing skills in English.
• Computer literate in Microsoft Word, Excel, PowerPoint, and working knowledge of Windows

Requirements:

: 01.03.2026

: 5 days per week

Location : Metropolitan region Munich