(Senior) Consultant Computer System Validation / IT Compliance - Freelancer

Arcondis Group; Frankfurt; Vor Ort; EUR 70.000 - 90.000; Vollzeit

Zusammenfassung

A consulting firm in Frankfurt seeks a (Senior) Consultant in Computer System Validation to lead initiatives ensuring GxP systems are audit-ready. Candidates should have 5 to 13 years of experience in CSV and a strong command of German. Responsibilities include developing documentation, collaborating with IT, and ensuring compliance with FDA regulations.

Qualifikationen

• 5 to 13 years of experience in computer system validation.
• In-depth knowledge of FDA regulations, EudraLex and GAMP5.
• Excellent command of German, spoken and written.

Aufgaben

• Lead computer system validation efforts for life sciences clients.
• Develop and implement lifecycle documentation for GxP systems.
• Collaborate with teams to design and execute validation plans.

Kenntnisse

Computer System Validation (CSV)

IT compliance

Testing automation

Regulatory compliance

Strong communication

Agile methodologies

DevOps

Ausbildung

Bachelor’s or Master’s degree in Computer Science, Engineering, Pharmaceuticals

Tools

SAP

Veeva Vault

LIMS

CTMS

MES

Jobbeschreibung

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

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