Senior Validation Engineer
Listed on 2026-07-01
-
Quality Assurance - QA/QC
Quality Engineering -
Engineering
Quality Engineering, Biomedical Engineer
Job Title
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 life cycles. 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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