CSV Engineer (m/f/d)

  Founded in 1968, SKAN is one of the pioneer companies in the specialist fields of cleanroom equipment and the development of isolators for the pharmaceutical industry. Innovative products, customer-specific solutions, and a powerful service and service organization have made SKAN a market leader and an important partner for industry and research laboratories. At a glance   To sustainably ensure and continuously develop the quality of our automation software, we are looking for an experienced Computer System Validation Engineer (CSV) for 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 meet the applicable quality and compliance requirements. The position offers a high degree of creative freedom as well as the opportunity to actively develop processes and take on responsibility. Please note that this role is not focused on software programming. The emphasis is on quality assurance, risk assessment, and compliance with regulatory requirements.   Tasks   • Further development and design of the testing procedure, taking into account regulatory requirements (especially GAMP 5 and 21 CFR Part 11) • Co-design and continuous improvement of internal processes in cooperation with adjacent specialist departments • Coordination of quality-relevant activities between the automation departments, Quality Assurance, and Product Management • Creation and maintenance of specifications and requirements for automation software • Planning, execution, and documentation of software tests as well as conducting reviews • Conducting risk analyses within the framework of the software testing process • Management and maintenance of validation documentation (e.g., test plans, test protocols, and test reports) • Creation and maintenance of training materials, work instructions, and guidelines • Conducting training for internal stakeholders • Support during audits and inspections within your own area of responsibility   Hardskills   • Completed studies in engineering, natural sciences, computer science, or a comparable field of study • Several years of professional experience in a GMP-regulated environment, ideally in the area of Computer System Validation (CSV), automation, or quality assurance • Sound knowledge of the relevant regulatory requirements, especially GAMP 5 and 21 CFR Part 11 • Experience in the creation, execution, and documentation of software validations • Basic understanding of software architectures, programming logic, and automated systems • Proficient use of common IT applications and electronic documentation systems • Very good English skills, written and spoken; German skills are an advantage     Softskills   • Strong communication skills and a confident manner towards internal stakeholders • High level of personal responsibility as well as an independent and structured way of working • Analytical thinking skills and a solution-oriented approach • Ability to convey complex topics in an understandable way • Organizational and coordination strength • Quality awareness as well as a high degree of accuracy and reliability       We offer • An open and collegial corporate culture • Freedom for ideas • Participation in sports and leisure activities • Support through further training, especially at our SKAN Academy • Intensive and job-oriented induction • Short decision-making paths and flat hierarchies • Open communication policy • 5 weeks of vacation and the possibility of additional vacation days     Further information   We look forward to receiving your complete application documents (CV, diplomas, and work certificates), which you can submit directly via our career page. For this vacancy, we rely on direct applications and do not work with external agencies. Submitted dossiers from agencies will not be processed.   If you have any questions, please contact Angelika Läuchli.