Process Validation Engineer

Our client is looking for a Process Validation Engineer to support them with the validation of a new clean room, equipment and process for the introduction of an implant product. The client is driving for IMB approval and as such requires the Process Validation engineer to be strong in writing validation documentation.

Key requirements:
Responsible for the validation of a clean room. All equipment is currently being purchased, as well as the manufacturing process.
Writing of validation documentation for the clean room, equipment and processes.
Validation of a new water purification line to support the new clean room.
Support the internal and external audit efforts.
Involvement and general support to the product transfer group including execution of assigned projects.

Qualifications/Requirements:
Extensive experience in a Medical Device environment.
Excellent knowledge of clean room and water systems validation, including documentation and execution.
Strong knowledge of equipment validation in a medical device environment.
Knowledge of medical device quality standards/regulatory requirements for the Irish Medical Board.
Education and experience in engineering, quality or scientific background is very advantageous.