Description
Sterilisation Process Validation EngineerLocation: Shannon Ireland
Duration: 6-9 months
Our client is looking for a Process Validation Engineer to support them with the validation of the contract sterilisation 3rd party as part of the introduction of a new product. The client is driving for IMB approval and as such requires the Process Validation Engineer to support with relevant documentation and audit preparation.
Key requirements:
• Responsible for the validation of contract sterilisation for both Gamma Irradiation and EO sterilization as per ISO , ISO , ISO , ISO .
• Responsible for the maintenance of the quarterly Dose Audit programme for all sterilisation families.
• Responsibility for implementing regulatory requirements in accordance with ISO13485, FDA QSR 21CFR Part 820.
• Involvement in Cleanroom validations, Water system validations and Cleaning validations.
• Involvement in the implementation and maintenance of the microbiological programme including environmental monitoring programmes, (air, surface and particulate) and purified water process monitoring.
• Preparation, execution and analysis of related Quality documentation.
• Support the internal audit program.
• Involvement and general support to the Quality group including execution of assigned projects.
Qualifications/Requirements:
• Extensive experience in a Medical Device environment.
• Experience of sterilisation validation, ideally Gamma Irradiation desired.
• Knowledge of water systems, Cleanrooms or biocompatibility is desirable.
• Knowledge of medical device quality standards/regulatory requirements as listed above.
• Education and experience in a microbiology, chemistry or related scientific background is very advantageous.