Beschreibung
For a well-known medical devices company I am currently looking for a Validation Engineer/Specialist.The Validation Engineer/Specialist will be responsible for the qualification and Validation of manufacturing Equipment, premises, methods, systems and processes.
The individual will work in close collaboration with R&D and Manufacturing at the company´s sites in Germany.
conditions:
- freelance
- 6 months with possible extension
- possibility of a leading role in the company and following Projects at their productions in the Nordics and border between Europe and Asia
- asap
principal responibilities:
- the process for company´s Validation and qualification process; manage, maintain and improve Validation processes
- working with R&D on technical Transfer activities
- all qualification and Validation activities for Equipment, processes and facility
- data Management and process Monitoring activities (Statistical Process Control)
- supporting local and international Audits (Notified Bodies, ANVISA, U.S. FDA, SFDA, KFDA, etc.) regarding Validation Topics
requirements:
- universitiydegree
- Minimum 3 years of Aggregate experience working with practical process Validation work (preferred medical devices and pharmaceutical industries)
- knowledge of, ad experience with regulations anf Guidelines pertaining to the med dev industry, including ISO 13485, CFR 820 and med dev directive
- experiencewith: planning, executionanddocumentationofqualificationandValidationprocesses, FocusonmanufacturingprocessValidationandcahngecontrols
If you are interested do not hesitate to contact me!
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