Sterilization and Decontamination Validation Sme - Toronto, Canada - Capgemini

Capgemini

Verified Company

Toronto, Canada

2 weeks ago

Posted by:

Sophia Lee

beBee Recruiter

Description

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 nonconformances.
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 Ebeam 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 Ebeam.
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 nonconformances.
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 revalidation frequencies in SAP (or equivalent thereto).