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# Senior Engineer CSV

- **Company:** Exyte AG
- **Location:** Leverkusen, Germany
- **Experience:** Expert
- **Contract:** Permanent contract
- **Skills:** System Testing, Computerised Systems, Information Technology
- **Published:** November 13, 2026
- **Apply:** https://www.careerjet.de/jobad/decbd1b5607d1a34a0aea65bc3f6f04a04

## About the Role

* Degree in Computer Science, Automation Engineering, Engineering, Pharmaceutical Technology, Life Sciences, or a related discipline.
 * Minimum 5 years of professional experience in computer system validation and/or IT infrastructure qualification within the life sciences industry.
 * Strong knowledge of relevant regulations and standards, including EU GMP, 21 CFR Part 11, ISO 13485, and MDR.
 * Experience with risk-based validation methodologies and GMP compliance requirements.
 * Strong analytical and problem-solving skills.
 * Fluent in both German and English.
 * Willingness to travel combined with a strong customer and service-oriented mindset.

## Description

Join us in delivering innovative projects for the pharmaceutical and biotechnology industries. In this role, you will ensure the compliance and validation of computerized systems while contributing to high-quality solutions in GMP-regulated environments.
Explore your tasks and responsibilities

 * Independently plan and execute Computerized System Validation (CSV) projects within GMP-regulated environments.
 * Prepare and execute risk-based validation documentation and validation activities.
 * Perform GMP gap analyses and risk assessments for computerized systems.
 * Advise clients on IT quality management and compliance-related topics.
 * Develop and improve CSV-related quality processes, policies, and SOPs.
 * Conduct trainings, workshops, and IT compliance audits.
 * Support CAPA implementation and follow-up activities.