Job TitleRequirements:Minimum five (5) years of experience specific/applicable to the below requirements.Support the completion of the following LBE Projects:Equipment/systems lifecycle management support for the commercial launch of Medical Device.Transition activities supporting new systems/equipment/components for perfusion services/devices used at facilities, facility change activities.Develop, revise, review and execute validation documents in support of equipment lifecycles. Documents include but are not limited to:User Requirement SpecificationsValidation Determination AssessmentsStandards Qualification FormsInstallation/Operational/Performance QualificationsRequirements Traceability MatrixSummary/Final ReportsServe as on-site support/contact for:Validation contractors:Meet with contractors, perform pre-review of validation documents to support efficient review/approval by QA.Lead the effort for protocol discrepancy related documentation and assist contractors in investigations related to protocol deviations.Operations:Collaborate with operations team to assess and update validation documents (VDAs, URS, Specifications, Trace documents) in support of user needs, process changes, and business improvements, and commercialization efforts.Support validation/qualification efforts for facility expansion.Quality Assurance:Maintaining validated state of equipment. Ensure equipment parameters are maintained, especially after calibration/maintenance events.Ensuring efficient and coordinated executions of validation events.
Work with QA/Clinical team to minimize disruption to clinical operations.Execute validation protocols. Perform/support periodic review cycles for LBE equipment. Assist with device related installation activities.Act as a validation/equipment point of contact for Facility Managers and Quality Assurance.Lead equipment/asset management process (for QA group) utilizing the Blue Mountain RAM system (electronic Asset/Equipment Manager).Collaborate with on-site contractors/operations team to document calibration/PM work and electronically manage equipment assets.Ensure RAM system, facility equipment, and equipment identification are aligned to support equipment control/management throughout the lifecycle.