Senior Validation Engineer
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Requirements
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 Specifications
Validation Determination Assessments
Standards Qualification Forms
Installation/Operational/Performance Qualifications
Requirements Traceability Matrix
Summary/Final Reports
Serve 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.
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