R&D Validation Engineer

Our client is an international company and one of the largest employers in the region. One of the main activities of the company is the design and manufacture of highly specialized equipment and diagnostic tools. Our client is a world leader in this industry.

The area of responsibility will cover steps from defining validation processes (procedures) via execution and document the results.

A central part of the job will be to:

• Validation planning, execution and documentation
• Assessment of validation need for tools and test systems
• Create/update validation procedures
• Support teams responsible for validation performance on all stages
• Results evaluation and preparation of validation reports, archive them and supervising updates of documentation
• Preparation and realization of process validation training courses
• Realization of internal audits in relation to FDA validation and requirements
• Oversee validation for all tools and test systems in Szczecin, Copenhagen and Bern
  
  The job will require some travel activities,.

Experience & education & skills


Our Client prefers that you have a bachelor or master degree in engineering.


Primary areas of your experience:

• Validation within the area of Medical devices and Development tools
• Knowledge of FDA requirements will be an advantage
• Preparation of documentation for validation process according to FDA requirements
• Risk assessment
• Technical documentation and reports for audits
• Excellent English skills

Other skills:

• Quality minded
• Service minded
• Communication skills
• Good teamwork and proactiveness
• Systematical and methodical approach (e.g. structured documenting skills)
• Curious and critical mindset

• Attractive salary and benefit package
• International and dynamic environment
• Continuous learning and development including best training programs
• Great work atmosphere