20 beste Stellen als research engineer in basilea bs – aktuell auf Personalsuche

CSV Engineer
SKAN AG —Allschwil, BL
- Informatik
- Englisch
- Kommunikationsfähigkeit
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CSV Engineer

SKAN AG -
Allschwil, BL

Jetzt bewerben

Details zur Stelle

Leistungen

Zusätzliche Ferientage

Qualifikationen

Informatik
Englisch
Qualitätssicherung
Kommunikationsfähigkeit
Deutsch

Vollständige Stellenbeschreibung

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.

Jetzt bewerben

Erweiterte Suche

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