Medartis AG
Basel
11 hours ago
Computer System Validation Manager 100%
- 11 February 2026
- 100%
- Permanent position
- Basel
Job summary
Join Medartis as a Computer System Validation Manager in Basel! Enjoy a dynamic work environment with excellent benefits.
Tasks
- Lead all validation and qualification activities for computer systems.
- Identify GMP-relevant computer systems using a risk-based approach.
- Create and maintain CSV framework documents and templates.
Skills
- Degree in science, engineering, or business with CSV experience required.
- Strong knowledge of GxP regulations and ISO 13485 guidelines.
- Excellent communication skills in German and English, French a plus.
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About the job
Technology, compliance, and quality are inseparably linked for you?
Then apply now at our location in Basel as
Then apply now at our location in Basel as
Computer System Validation Manager 100%
Your area of responsibility
- Overall responsibility as project manager for all validation and qualification activities of computer systems (CS) as well as the ICT infrastructure
- Identification of all GMP-relevant computer systems based on a risk-based methodology
- Creation of qualification and validation plans as well as reports
- Preparation and leadership of risk analyses according to FMEA
- Support in the creation of URS (User Requirement Specification) and test plans, as well as their review
- Evaluation of change requests on validated CS and processing of changes
- Creation, further development, and maintenance of the CSV framework (SOPs/forms/templates)
- Coaching of internal and external resources in validation topics Conducting training for personnel qualification for CSV activities
Your qualifications
- Completed studies (BSc / MSc) in a scientific, technical, or business field or comparable further education/training in the field of CSV in a regulated environment
- At least 3 years of practical experience in CSV and ICT infrastructure qualification, of which at least 2 years in medical technology
- Initial experience in planning, conducting, and follow-up of audits (authority and supplier audits)
- Proven knowledge of relevant regulations and guidelines in the areas of GxP and medical technology (ISO 13485, FDA 21CFR Part 820 and 11, GAMP)
- Experience with Product Life Cycle Management, document control systems, and ERP systems (especially SAP)
- High IT affinity and technical understanding
- Confident handling of Office applications
- Very good German and English skills, French is an advantage
- Independent, structured, and agile working style as well as very good communication skills
What we offerWe offer you a responsible and varied activity with high quality requirements in a growing, international company with progressive social benefits.
About MedartisMedartis is one of the leading manufacturers of medical products for osteosynthesis in the field of the facial skull and extremities. Medartis is committed to the well-being of patients by providing surgeons and OR staff with the most innovative titanium implants and instruments and offering the best service.
For more information, please visit our homepage www.medartis.com.
We look forward to receiving your complete online application.
We look forward to receiving your complete online application.
Medartis
Human Resources
jobs@medartis.com
www.medartis.com
Human Resources
jobs@medartis.com
www.medartis.com
