CSV Engineer

Further develop and design testing procedures in compliance with regulatory requirements (in particular GAMP 5 and 21 CFR Part 11) Contribute to the development and continuous improvement of internal processes in collaboration with related departments Coordinate quality-related activities between the Automation departments, Quality Assurance, and Product Management Create and maintain specifications and requirements for automation software Plan, perform, and document software tests and conduct reviews Perform risk analyses as part of the software testing process Manage and maintain validation documentation (e.g., test plans, test protocols, and test reports) Create and maintain training materials, work instructions, and guidelines Conduct training sessions for internal stakeholders Support audits and inspections within your area of responsibility

Founded in 1968, SKAN is a pioneer in cleanroom equipment and the development of isolators for the pharmaceutical industry. Innovative products, tailor-made solutions and an effective service organization have made SKAN a market leader and a key partner to industry and research laboratories.

• Degree in Engineering, Natural Sciences, Computer Science, or a comparable field

• Several years of professional experience in a GMP-regulated environment, ideally in Computer System Validation (CSV), automation, or quality assurance

• 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; German language skills are an advantage

• 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