Medartis AG
Basel
Yesterday
Computer System Validation Engineer 100%
- 05 May 2026
- 100%
- Permanent position
- Basel
Job summary
Join Medartis in Basel as a Computer System Validation Engineer!
Tasks
- Lead project activities for computer system validation and qualification.
- Identify GMP-relevant systems using a risk-based methodology.
- Prepare and conduct risk analyses and support user requirements.
Skills
- Degree in a scientific, technical, or business field with CSV experience.
- Strong knowledge of GxP regulations and medical device 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 in Basel as
Then apply now in Basel as
Computer System Validation Engineer 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 management of risk analyses according to FMEA
- Support in the creation of the URS (User Requirement Specification) and test plans, as well as their review
- Evaluation of change requests to 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 degree (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 (regulatory 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 as well as ERP systems (especially SAP)
- High IT affinity and technical understanding
- Confident use of Office applications
- Very good German and English skills, French 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 MedartisAt Medartis we combine innovative solutions with qualified specialists to be the preferred provider in orthopaedics. The Medartis Group was founded in 1997 and is headquartered in Basel, Switzerland. It is one of the world’s leading manufacturers and providers of medical technology for the surgical treatment of bone fractures of the upper and lower extremities as well as in the cranio-maxillofacial area. The company employs around 1,400 people at 13 locations and sells its products in over 50 countries worldwide.
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
