IT Specialist - Computer System Validation | Informatiker (m/w/d)
R-Biopharm AG
Job Summary
This role involves the planning, coordination, and execution of Computer System Validation (CSV) for R-Biopharm, a leading biotechnology company. The successful candidate will be responsible for creating and maintaining critical validation documentation, including validation plans, risk analyses, and test reports, ensuring compliance with international standards such as ISO 13485 and IVDR. Day-to-day activities include performing IQ/OQ/PQ qualification tests, collaborating closely with quality management, and supporting the change control process. This position is ideal for professionals who enjoy interdisciplinary teamwork and want to contribute to the healthcare sector within a stable, family-owned business. The role is particularly attractive due to its comprehensive benefits package, including mobile work options, flexible hours, and a strong focus on employee health and professional development in a modern Darmstadt-based facility.
Required Skills
Education
Completed vocational training or degree in a STEM field (Science, Technology, Engineering, or Mathematics) or a comparable qualification.
Experience
- Initial professional experience in Computer System Validation (CSV) or working within quality-regulated environments.
- Experience in creating validation plans, test concepts, and SOPs.
- Professional experience in a STEM-related field (Science, Technology, Engineering, or Mathematics).
- Experience working with interdisciplinary teams and participating in audits or inspections.
Languages
Additional
- The role is based in Darmstadt and requires the ability to work on-site, though mobile work options are available. Candidates must be able to handle documentation with high precision and work within strict regulatory frameworks.