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.
iii. Execute validation protocols.
iv. Perform/support periodic review cycles for LBE equipment.
v. 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.
