Senior Validation Engineer

Senior Validation Engineer 4.0 4.0 out of 5 stars Silver Spring, MD 20815 Contract Katalyst Healthcares & Life Sciences 4 reviews

Contract 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.