Qualification & Validation Engineer

Position: Qualification and Validation Engineer
Place of work: Zuchwil, Solothurn
Beginning of employment: 18.07.2016
End of employment: 16.10.2016
Workload: 100%/40 hours
Your availability: Immediate

Knowledge

* Knowledge of bespoke validation, in depth knowledge of 21 CFR 820, 21 CFR 11 and European regulations associated with the medical device industry, high understanding of GMP, Compliance, Validation Practices including the system development life cycle and Regulatory expectations. CSV.
* Working experience of validation computer systems for use in a FDA regulated environment must be able to lead and give direction to Validation Projects and Teams.
* Minimum of 2 - 5 years working in a regulated industry a minimum 2 of which has been spent carrying out validations.

Non-Technical profile requirements:

* Some flexibility in working hours is required
* Must be able to work on multiple simultaneous tasks with limited supervision; - Quick learner, motivated self-starter
* Excellent customer service, interpersonal, communication and team collaboration skills; - Able to follow change management for internal guidelines.
* Language proficiencies: -English spoken and written;