CSV Engineer
On-siteAllschwil, Basel-Landschaft, Switzerland
Job Summary
Design and optimize testing procedures for automation software in compliance with GAMP 5 and 21 CFR Part 11. Plan, perform, and document software tests while conducting risk analyses and managing validation documentation. Coordinate quality-related activities across Automation, Quality Assurance, and Product Management departments. Create specifications, requirements, and training materials to support internal stakeholders. Support audits and inspections within your area of responsibility. This role offers a high degree of autonomy to actively develop processes and take ownership, situated within SKAN's Automation Software QC Team.
Required Qualifications
- Degree in Engineering, Natural Sciences, Computer Science, or a comparable field
- Several years of professional experience in a GMP-regulated environment
- Well-founded knowledge of relevant regulatory requirements, particularly GAMP 5 and 21 CFR Part 11
- Experience in the creation, execution, and documentation of software validation activities
- Basic understanding of software architectures, programming logic, and automated systems
- Confident use of common computer applications and electronic documentation systems
- Excellent written and spoken English skills
- Strong communication skills and confidence when interacting with internal stakeholders
- High level of personal responsibility and an independent, structured way of working
- Analytical mindset and solution-oriented approach
- Ability to explain complex topics in a clear and understandable manner
- Strong organizational and coordination skills
- Strong quality awareness combined with a high degree of accuracy and reliability
Desired Qualifications
- ideally in Computer System Validation (CSV), automation, or quality assurance
- German language skills
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