Computer System Validation Specialist | Spezialist Computersystemvalidierung (m/w/d)
engineering people GmbH
Job Summary
As a Computer System Validation (CSV) Specialist based in Leipzig, you will be responsible for ensuring that all software and computerized systems meet rigorous regulatory requirements and data integrity standards. Your daily activities will involve advising specialized departments on CSV interpretations, managing deviations, and processing change requests. You will play a critical role in optimizing Standard Operating Procedures (SOPs) and harmonizing the process landscape. A significant portion of the role focuses on the system validation of small equipment, packaging, and filling lines using the V-Model and GAMP 5 frameworks. This position is ideal for professionals with a background in Life Sciences who enjoy bridging the gap between technical system performance and strict regulatory compliance in a production environment.
Required Skills
Education
Degree in Pharmacy, Biotechnology, Chemistry, or a comparable qualification.
Experience
- Professional experience in Computer System Validation (CSV) according to the V-Model
- Practical experience in the validation of production and packaging systems
- Demonstrated knowledge of GAMP 5 guidelines and data integrity standards
- Experience in managing change requests and deviations within a regulated environment
Languages
Additional
- Location: Leipzig. Full-time position. Requires expertise in Life Science regulatory environments.