Requirements

Operating system

Windows

Our requirements

• University degree in IT, engineering, natural sciences, or a related discipline.
• At least 4 years of experience in CSV, IT validation, quality assurance, or IT compliance, ideally within the pharmaceutical or medical device industry.
• Deep understanding of GxP requirements and regulatory frameworks such as EU GMP Annex 11, FDA 21 CFR Part 11, and GAMP 5.
• Proven ability to manage validation projects across diverse systems and stakeholder groups.
• Experience with medical device regulatory frameworks (e.g., MDD, MPG, EU-MDR) is a plus.
• Strong analytical and problem-solving skills with a structured, detail-oriented approach.
• Excellent communication skills and the ability to operate confidently in international, cross-functional environments.
• Fluent English skills (written and spoken); German language skills are an advantage.
• Proficient in Microsoft Office and familiar with tools such as JIRA, ServiceNow, Solution Manager, or TrackWise.

Your responsibilities

• Lead and manage validation activities for IT systems to ensure compliance with pharmaceutical regulatory requirements and internal quality standards.
• Support the design and implementation of a global IT validation strategy in line with GxP and other relevant regulatory guidelines.
• Create and maintain comprehensive lifecycle documentation, including validation/test plans, risk assessments, traceability matrices, and summary reports.
• Develop and review CSV policies, procedures, and validation documentation to ensure regulatory compliance and good documentation practices.
• Manage validation records and documentation across projects and systems in a structured and audit-ready manner.
• Conduct periodic reviews of validated systems and evaluate changes to assess re-validation needs.
• Schedule and lead cross-functional meetings with IT, Quality, and Business stakeholders to align on project scope, risks, and execution plans.
• Act as a subject matter expert during internal and external audits, supporting CSV-related discussions and documentation.
• Stay current on regulatory trends and industry best practices in computerized system validation; provide training and guidance across departments.
• Contribute to the continuous improvement of the validation process, tools, and templates to enhance efficiency and compliance.