Duration: 12-24 months
Start Date: End of January
Role Details:
- Work with Principal Quality Assurance Engineer to develop, revise, review 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.
- At direction of Principal QA Engineer, execute validation protocols.
- Perform/support periodic review cycles for equipment
- Act as a validation/equipment point of contact for Facility Managers and Quality Assurance.
- Lead equipment/asset management process utilizing the Blue Mountain RAM system.
- Ensure RAM system, facility equipment, and equipment identification are aligned to support equipment control/management throughout the lifecycle.
MA: Validation Engineer (236483)
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