CSV Engineer

Über den Job

CSV Engineer

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.

At a glance

To ensure and continuously improve the quality of our automation software, we are looking for an experienced Computer System Validation Engineer (CSV) to join our Automation Software QC Team in Allschwil. In this role, you will design and optimize our testing 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 comply with applicable quality and compliance requirements. This position offers a high degree of autonomy as well as the opportunity to actively develop processes and take ownership of responsibilities.

Please note that this role is not focused on software programming. The main focus is on quality assurance, risk assessment, and compliance with regulatory requirements.

Responsibilities

• 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

Hardskills

• 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

Softskills

• 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

We offer you

• An open and collaborative corporate culture
• Freedom to contribute and develop ideas
• Opportunities to participate in sports and social activities
• Professional development and continuous learning opportunities, especially at our SKAN Academy
• Comprehensive and career-focused onboarding
• Quick decision-making paths and flat hierarchies
• Transparent and open communication
• 5 weeks of vacation, with the option to take additional leave

Additional information

We look forward to receiving your complete application documents (CV, diplomas and employment references) via our career page.

For this position, we are focusing on direct applications and are not working with external agencies. Any dossiers submitted by agencies will not be processed.

For questions please contact Angelika Läuchli.