{"schemaVersion":"jobsearcher.job.v1","id":"eb51618cee8cceb6d0068254","url":"https://jobsearcher.com/jobs/eb51618cee8cceb6d0068254","canonicalUrl":"https://jobsearcher.com/jobs/eb51618cee8cceb6d0068254","title":"Senior Validation Engineer","description":"Requirements\n\nMinimum five (5) years of experience specific/applicable to the below requirements.\n\nSupport the completion of the following LBE Projects:\n\nEquipment/systems lifecycle management support for the commercial launch of Medical Device.\n\nTransition activities supporting new systems/equipment/components for perfusion services/devices used at facilities, facility change activities.\n\nDevelop, revise, review and execute validation documents in support of equipment lifecycles. Documents include but are not limited to:\n\nUser Requirement Specifications\n\nValidation Determination Assessments\n\nStandards Qualification Forms\n\nInstallation/Operational/Performance Qualifications\n\nRequirements Traceability Matrix\n\nSummary/Final Reports\n\nServe as on-site support/contact for:\n\nValidation contractors\n\nMeet with contractors, perform pre-review of validation documents to support efficient review/approval by QA.\n\nLead the effort for protocol discrepancy related documentation and assist contractors in investigations related to protocol deviations.\n\nOperations\n\nCollaborate 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.\n\nSupport validation/qualification efforts for facility expansion.\n\nQuality Assurance\n\nMaintaining validated state of equipment. Ensure equipment parameters are maintained, especially after calibration/maintenance events.\n\nEnsuring efficient and coordinated executions of validation events. Work with QA/Clinical team to minimize disruption to clinical operations.\n\nExecute validation protocols.\n\nPerform/support periodic review cycles for LBE equipment.\n\nAssist with device related installation activities.\n\nAct as a validation/equipment point of contact for Facility Managers and Quality Assurance.\n\nLead equipment/asset management process (for QA group) utilizing the Blue Mountain RAM system (electronic Asset/Equipment Manager).\n\nCollaborate with on-site contractors/operations team to document calibration/PM work and electronically manage equipment assets.\n\nEnsure RAM system, facility equipment, and equipment identification are aligned to support equipment control/management throughout the lifecycle.\n\n#J-18808-Ljbffr","company":"Creative Solutions Services","rawCompany":"creative solutions services","city":"Silver Spring","state":"MD","isRemote":false,"isActive":false,"createdAt":"2026-07-08T03:18:35.930Z","occupations":[{"code":"17-2112.02","title":"Validation Engineers","slug":"validation-engineers"},{"code":"17-2031.00","title":"Bioengineers and Biomedical Engineers","slug":"bioengineers-and-biomedical-engineers"},{"code":"49-9062.00","title":"Medical Equipment Repairers","slug":"medical-equipment-repairers"}],"industries":[{"code":"334510","title":"Electromedical and Electrotherapeutic Apparatus Manufacturing","slug":"electromedical-and-electrotherapeutic-apparatus-manufacturing"},{"code":"339113","title":"Surgical Appliance and Supplies Manufacturing","slug":"surgical-appliance-and-supplies-manufacturing"},{"code":"339112","title":"Surgical and Medical Instrument Manufacturing","slug":"surgical-and-medical-instrument-manufacturing"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Senior Validation Engineer","description":"Requirements\n\nMinimum five (5) years of experience specific/applicable to the below requirements.\n\nSupport the completion of the following LBE Projects:\n\nEquipment/systems lifecycle management support for the commercial launch of Medical Device.\n\nTransition activities supporting new systems/equipment/components for perfusion services/devices used at facilities, facility change activities.\n\nDevelop, revise, review and execute validation documents in support of equipment lifecycles. Documents include but are not limited to:\n\nUser Requirement Specifications\n\nValidation Determination Assessments\n\nStandards Qualification Forms\n\nInstallation/Operational/Performance Qualifications\n\nRequirements Traceability Matrix\n\nSummary/Final Reports\n\nServe as on-site support/contact for:\n\nValidation contractors\n\nMeet with contractors, perform pre-review of validation documents to support efficient review/approval by QA.\n\nLead the effort for protocol discrepancy related documentation and assist contractors in investigations related to protocol deviations.\n\nOperations\n\nCollaborate 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.\n\nSupport validation/qualification efforts for facility expansion.\n\nQuality Assurance\n\nMaintaining validated state of equipment. Ensure equipment parameters are maintained, especially after calibration/maintenance events.\n\nEnsuring efficient and coordinated executions of validation events. Work with QA/Clinical team to minimize disruption to clinical operations.\n\nExecute validation protocols.\n\nPerform/support periodic review cycles for LBE equipment.\n\nAssist with device related installation activities.\n\nAct as a validation/equipment point of contact for Facility Managers and Quality Assurance.\n\nLead equipment/asset management process (for QA group) utilizing the Blue Mountain RAM system (electronic Asset/Equipment Manager).\n\nCollaborate with on-site contractors/operations team to document calibration/PM work and electronically manage equipment assets.\n\nEnsure RAM system, facility equipment, and equipment identification are aligned to support equipment control/management throughout the lifecycle.\n\n#J-18808-Ljbffr","datePosted":"2026-07-08T03:18:35.930Z","dateModified":"2026-07-08T03:18:35.930Z","hiringOrganization":{"@type":"Organization","name":"Creative Solutions Services","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Silver Spring","addressRegion":"MD","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"eb51618cee8cceb6d0068254"},"url":"https://jobsearcher.com/jobs/eb51618cee8cceb6d0068254"}}