Senior Validation Engineer

• 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.

1. Develop, revise, review and execute validation documents in support of equipment lifecycles. Documents include but are not limited to:
   1. User Requirement Specifications,
   2. Validation Determination Assessments,
   3. Standards Qualification Forms,
   4. Installation/Operational/Performance Qualifications,
   5. Requirements Traceability Matrix,
   6. Summary/Final Reports
2. Serve as on-site support/contact for:
   1. 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.
  1. 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.
  1. 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.