Validation Engineer (m/f/d)
About us:
We are a leading company in medical technology and are looking for a reliable validation engineer to strengthen our team. Our company places great value on efficiency, teamwork, and excellence in quality management and provides a supportive work environment for personal and professional growth.
Tasks:
Your main task as a validation engineer (m, w, d) is to qualify and validate plants, devices, processes and systems in our company. They are responsible for carrying out risk analyses with regard to new production processes, preparing qualification plans, reviewing qualification and validation documents, process documentation, evaluating results, and evaluating changes to validated processes.
Your day-to-day work includes close cooperation with the various departments of the company. They are in constant contact with QM, Technology, Quality Assurance and Production. You will also participate in supervising and training employees.
- Qualifying machines, devices and clean rooms
- Validate manufacturing, packaging, and EO sterilization processes
- Preparation and review of risk analyses, qualification plans and reports
- Review of qualification and validation documents, e.g. when changes to validated processes
- Preparation of process and QM documentation (Change Control, AA, PA, etc.)
- Participation in comments on government and customer inquiries
Qualification:
- Completed bachelor's or master's degree in medical technology or comparable qualification
- Profound practical experience in a medical device manufacturing company, ideally of non-active class 1 and 2 medical devices
- 2 — 3 years of practical experience in validation/qualification
- Knowledge of statistical methods for validating processes
- Knowledge of regulatory requirements for medical devices (ISO 13485, Medical Device Regulation MDR)
- Very good computer skills (MS Windows) and IT affinity
- Flexible, independent, structured and careful way of working as well as good communication and team skills
- Business fluency in German and very good spoken and written English skills
We offer:
- A challenging position in a motivated team
- Opportunities for personal and professional development
- An attractive salary package and additional social benefits, such as company pension plans, capital benefits
- Home office option (1 day)
- 30 days vacation per year and vacation and Christmas bonus
- A modern working environment and a pleasant working atmosphere
- The opportunity to contribute to the optimization of logistical processes
If you would like to become part of a dynamic team and take advantage of the opportunity to contribute and develop your warehouse skills, we look forward to receiving your detailed application at bewerbung@soellner.ag.
