CSV Engineer

• 31 July 2026 • 100% • Indefinite period • Allschwil CSV Engineer Founded in 1968, SKAN is a pioneer in the field of cleanroom equipment and isolator development for the pharmaceutical industry. Innovative products, tailor-made solutions, and an efficient service organization have made SKAN a market leader and a key partner for industry and research laboratories. At a glance To continuously guarantee and improve the quality of our automation software, we are looking for an experienced Computer Systems Validation (CSV) engineer to join our automation software quality control team in Allschwil. In this role, you will design and optimize our test procedures for automation software. You will work closely with the Automation, Quality Assurance, and Product Management departments and contribute to ensuring that our software solutions meet applicable quality and compliance requirements. This position offers a high degree of autonomy as well as the opportunity to actively develop processes and take on responsibilities. Please note that this role does not focus on software programming. The main emphasis is on quality assurance, risk assessment, and compliance with regulatory requirements. Responsibilities • Develop and further design test procedures in accordance 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 the relevant departments • Coordinate quality-related activities between the Automation, Quality Assurance, and Product Management departments • Create and maintain specifications and requirements for automation software • Plan, execute, and document software tests and perform reviews • Conduct 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 Technical skills • Degree in engineering, natural sciences, computer science, or a comparable field • Several years of professional experience in a GMP regulated environment, ideally in computer systems validation (CSV), automation, or quality assurance • In-depth knowledge of relevant regulatory requirements, in particular GAMP 5 and 21 CFR Part 11 • Experience in creating, executing, and documenting software validation activities • Basic understanding of software architectures, programming logic, and automated systems • Proficiency in common computer applications and electronic documentation systems • Excellent written and oral English skills; proficiency in German is an advantage Behavioral skills • Excellent communication skills and confidence in interactions with internal stakeholders • High sense of personal responsibility and an independent, structured way of working • Analytical mindset and a 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 precision and reliability We offer you • An open and collaborative corporate culture • The freedom to contribute and develop ideas • Opportunities to participate in sports and social activities • Opportunities for professional development and continuous learning, notably at our SKAN Academy • A comprehensive and career-oriented onboarding • Fast decision-making processes and flat hierarchies • Transparent and open communication • 5 weeks of vacation, with the possibility of taking additional leave Additional information We look forward to receiving your complete application documents (CV, diplomas, and professional references) via our career page. For this position, we prefer direct applications and do not work with external agencies. Any application submitted by agencies will not be processed. For any questions, please contact Angelika Läuchli.