Validation Engineer - Computer System Validation (Manufacturing) | Kontron AIS GmbH: Validation Engineer - Computer System Validation (m/w/d) Manufacturing
Kontron AIS GmbH
Job Summary
This role involves ensuring the safety and compliance of industrial manufacturing software solutions, particularly within the pharmaceutical sector. The Validation Engineer will be responsible for qualifying and validating computer systems, including those used by clients across Germany, Europe, and globally. Key tasks include creating GMP concepts and validation documents like Functional Requirement Specifications and risk analyses, supporting project managers in validation planning, and optimizing validation workflows. The ideal candidate will have an academic background in natural sciences or engineering, familiarity with pharmaceutical regulations (e.g., GAMP5, EU-GMP, 21 CFR Part 11/210), and a strong commitment to meticulous documentation and process improvement. This position offers the opportunity to contribute to cutting-edge industrial software, work with a supportive team, and ensure the highest standards of safety and compliance in critical manufacturing environments.
Required Skills
Education
Academic degree in natural sciences or engineering (Computer Science, Automation Technology, Pharmaceutical Technology, or comparable field)
Experience
- Professional experience in a scientific or engineering field (Computer Science, Automation Technology, Pharmaceutical Technology, or similar)
- Familiarity with national and international pharmaceutical regulations in the GMP environment (e.g., GAMP5, EU-GMP Guide, 21 CFR Part 11/210)
- Experience in careful documentation of work performed
- Experience in supporting internal and external audits in a GMP environment
Languages
Additional
- Willingness to travel extensively for multi-week business trips (potentially several times a year)