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Sterilisation Process Validation Engineer
Eingestellt von Quanta Consultancy Services
Gesuchte Skills: Support, Engineer
Projektbeschreibung
Sterilisation Process Validation Engineer
Location: 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 11137-1, ISO 11137-2, ISO 11137-3, ISO 11135-1.
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.
Location: 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 11137-1, ISO 11137-2, ISO 11137-3, ISO 11135-1.
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.
Projektdetails
Geforderte Qualifikationen
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Kategorie:
Ingenieurwesen/Technik, Sonstiges