(Senior) Consultant Computer System Validation / IT Compliance

Job 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.

Important Note: This is a pipeline posting to build our freelancer pool. There is no active project for this role today. We will review profiles on a rolling basis and contact you when a matching project starts.

Key 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