Stellenbeschreibung:

Overview

As a (Senior) Consultant - Computer System Validation (CSV), you will lead validation initiatives to keep GxP systems compliant and audit-ready (e.g., 21 CFR Part 11 / 820, EudraLex, GAMP 5). You will define lifecycle strategies, author / execute tests, and steer automation across cloud and enterprise platforms (e.g., SAP, Veeva, CTMS, MES, LIMS), partnering with IT, Quality, and Regulatory in Agile / DevOps settings. You will also advise on GxP AI validation and strengthen documentation and quality processes (change, deviations, CAPA) while managing multiple projects.

Responsibilities

• Lead and oversee computer system validation (CSV) efforts for life sciences clients, ensuring adherence to regulatory requirements such as 21 CFR Part 11 and 21 CFR Part 820, but not limited
• Develop and implement comprehensive lifecycle documentation for GxP relevant computer systems, including the creation and execution of test protocols
• Review technical documentation and support IT compliance strategies to maintain the security, reliability, and regulatory compliance of computer systems
• Collaborate with cross-functional teams, including IT, Quality, and Regulatory, to design and execute validation plans for both new and existing computer systems and digital initiatives
• Provide expert guidance and support on CSV and automation testing, ensuring best practices and regulatory compliance
• Experienced in DevOps, Agile, Scrum, Waterfall, and ITIL methodologies, with a strong understanding of industry best practices
• Experience on validation of GxP AI Solutions

Qualifications, Skills and Experience

• Bachelor’s or Master’s degree in Computer Science, Engineering, Pharmaceuticals, or a related field
• Minimum of 5 to 13 years of experience in computer system validation (CSV), Infrastructure qualification, IT compliance, testing automation, or related disciplines
• In-depth knowledge of relevant regulations and industry best practices, including FDA regulations, EudraLex and GAMP5
• Proven ability to lead and manage multiple CSV projects and digital initiatives, including documentation development, testing efforts, and compliance assurance
• Experience with testing automation tools, process-controlled systems, application lifecycle management tools and paper-based testing
• Strong communication skills with the ability to work effectively with cross-functional teams
• Expertise in cloud-based solutions, and on different critical systems like SAP, Clinical Trial Management Systems (CTMS), Veeva Vault, Manufacturing Execution Systems (MES), Laboratory Information Management Systems (LIMS), electronic Lab Notebooks (eLN), change management, deviation and CAPA processes, as well as experience with AI / ML, automation, and Robotic Process Automation (RPA) is a plus
• Strong facilitation skills with excellent organizational and interpersonal abilities
• Willingness to travel to customer site as required
• Excellent command of German, spoken and written
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