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 is for a Validation Engineer focused on Computer System Validation within industrial manufacturing, specifically for the pharmaceutical sector. The successful candidate will be responsible for qualifying and validating computer systems for clients across Germany, Europe, and globally. Key tasks include creating GMP concepts and qualification documents such as Functional Requirement Specifications, Risk Analyses, and IQ/OQ Test Plans. The role also involves supporting project managers in validation planning, optimizing validation workflows, and assisting with change management and GMP compliance. This position is ideal for someone passionate about ensuring the highest safety standards in industrial software, contributing to continuous process improvement, and actively participating in team discussions and external/internal audits.
Required Skills
Education
Academic degree in Natural Sciences or Engineering (Computer Science, Automation Technology, Pharmaceutical Technology, or comparable)
Experience
- Professional experience in a natural science 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 Guidelines, 21 CFR Part 11/210)
Languages
Additional
- Willingness to travel frequently for multi-week business trips (potentially several times a year)
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