Sterilization and Decontamination Validation Sme

2 weeks ago

Toronto, Canada Capgemini Full time

Location: Toronto, ON
- Plan, coordination and Drive Thermal validation activities of Autoclaves may include, but not limited to:

- Review of Design documents, Development of validation plan/strategy
- Review of IQ, OQ and PQ.
- Reviewing of item diagrams and coordinating with operation for Load readiness.
- Support raw data review and provide input as required.
- Provide support of investigation and closure for punch list items and non-conformances.
- Provide support for assessing and closing change controls.
- Ensure BI availability, release testing and processed testing in a timely fashion.
- Management of conflicting priorities
- Ensure all protocol/test study, reports are completed within specified timelines.
- Plan, coordination and Drive validation activities of Isolator, SARAP and E-beam may include, but not limited to:

- Support Site Acceptance testing and cycle development for E-beam, SARAP and VHP Isolator
- Review of Design documents, Development of validation plan/strategy
- Review of IQ, OQ and PQ.
- Coordinating with operation for Load readiness.
- Ensure logistics around dosimetry strips for E-beam.
- Ensure BI and CI availability, release testing and processed testing in a timely fashion.
- Support raw data review and provide input as required.
- Provide support of investigation and closure for punch list items and non-conformances.
- Provide support for assessing and closing change controls.
- Management of conflicting priorities
- Ensure all protocol/test study, reports are completed within specified timelines.
- Documentation support/ Schedule Coordination to ensure compliance and adherence to project schedules. Documentation support includes, but is not limited to:

- Support/review/update of SOPs and/or Work Instructions.
- Preparation of standalone technical assessments, Item diagrams review, generation/review of PM (Preventative Maintenance) Task list, template/supplement update or creation.
- Create Risk assessments and/or Strategy for timely execution.
- Coordinate document preparation and execution activities with Workstream Leads, ensuring deliverable are completed on time.
- When needed, enlist the timely support of the site sterilization/decontamination validation team to facilitate test script execution and to troubleshoot and resolve observed issues.
- Issue new/update existing SOP(s) and provide SME feedback/comments on procedure generated by others that are related to sterilization and decontamination processes.
- Generate and issue Preventive Maintenance Task Lists required to set up the re-validation frequencies in SAP (or equivalent thereto).

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