Validation Engineer
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VALIDATION ENGINEERBelvidere, IL | Direct Hire | Full-Time | Onsite⚠ WORK AUTHORIZATION REQUIREMENTApplicants must be authorized to work in the United States without current or future sponsorship.This employer DOES NOT provide:H-1B SponsorshipH-1B TransfersOPT/CPT SponsorshipTN SponsorshipEmployment-Based Visa Sponsorship of Any KindCandidates requiring sponsorship now or in the future will not be considered.ABOUT THE OPPORTUNITYJoin a growing employee-owned automation company that designs and builds custom high-speed assembly equipment for the:Medical Device IndustryConsumer Products IndustryIndustrial Manufacturing IndustryWe are seeking a Validation Engineer to support equipment qualification, commissioning, and validation activities for custom automation systems.RESPONSIBILITIESValidation & QualificationDevelop and execute:Design Qualification (DQ)Installation Qualification (IQ)Operational Qualification (OQ)Performance Qualification (PQ)Testing & CommissioningSupport Factory Acceptance Testing (FAT)Support Site Acceptance Testing (SAT)Assist with equipment commissioning activitiesDocumentationCreate and maintain:Validation ProtocolsQualification ReportsCommissioning DocumentationTechnical DocumentationEngineering CollaborationPartner with Engineering teams to develop and review:Functional Design SpecificationsSoftware Design SpecificationsHardware Design SpecificationsVision System SpecificationsOperator ManualsCompliance & Risk ManagementPerform Risk AssessmentsParticipate in FMEA ActivitiesSupport cGMP Compliance ReviewsMaintain validation records within Kneat GxQUALIFICATIONSRequiredAssociate Degree in Engineering Technology, Manufacturing Technology, or related field3+ years of validation experience in a regulated manufacturing environmentExperience with:DQ, IQ, OQ, and PQ ProtocolsFAT and SAT ActivitiesEngineering Drawings and Technical DocumentationcGMP RequirementsAPPLY TODAYIf you have experience validating equipment in a regulated manufacturing environment and are looking to join a stable, employee-owned organization, we encourage you to apply.