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 Sponsorship Employment-Based Visa Sponsorship of Any Kind Candidates requiring sponsorship now or in the future will not be considered.
ABOUT THE OPPORTUNITY:
Join a growing employee-owned automation company that designs and builds custom high-speed assembly equipment for the: Medical Device Industry Consumer Products Industry Industrial Manufacturing Industry We are seeking a Validation Engineer to support equipment qualification, commissioning, and validation activities for custom automation systems. RESPONSIBILITIESValidation & Qualification Develop and execute: Design Qualification (DQ) Installation Qualification (IQ) Operational Qualification (OQ) Performance Qualification (PQ) Testing & Commissioning Support Factory Acceptance Testing (FAT) Support Site Acceptance Testing (SAT) Assist with equipment commissioning activities DocumentationCreate and maintain: Validation Protocols Qualification Reports Commissioning Documentation Technical Documentation Engineering Collaboration Partner with Engineering teams to develop and review: Functional Design Specifications Software Design Specifications Hardware Design Specifications Vision System Specifications Operator Manuals Compliance & Risk Management Perform Risk Assessments Participate in FMEA Activities Support cGMP Compliance Reviews Maintain validation records within Kneat GxQUALIFICATIONSRequiredAssociate Degree in Engineering Technology, Manufacturing Technology, or related field 3+ years of validation experience in a regulated manufacturing environment Experience with: DQ, IQ, OQ, and PQ ProtocolsFAT and SAT Activities Engineering 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.