Beschreibung
Validation Engineer: FDA, GMP, 21 CFR 820, 21 CFR 11, German
My client requires a validation Engineer To provide support for the validation activities associated with equipment, reagents, facilities, cleaning, test methods, and environment ensuring that all compliance issues and requirements of company Validation Policies and Procedures are addressed.
Fluent in English and German, you must have the following experience to be considered for this role.
- Knowledge of bespoke validation.
-Process knowledge and documentation.
Desirable:
-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.
-Working experience of validation computer systems for use in a FDA regulated environment. Non-Technical Profile Requirements
-Must be able to lead and give direction to Validation Projects and Teams.
-Individual must also be an active team member in Validation activities Methodology/Certification Requirements
-Minimum of 2 years working in a regulated environment a minimum 1 of which has been spent carrying out validation and/or testing activities.
Validation Engineer: FDA, GMP, 21 CFR 820, 21 CFR 11, German