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San Jose, United States Intellectt Inc Full timePosition: Validation EngineerLocation: San Jose, CADuration: 12monthsJob duties:Process and equipment qualification (IQ/OQ/PQ).Development of test methods for Design V&V, Process Validation, and ProductionValidation of test methodsExecution of Engineering Builds, Gauge R&R Studies, Attribute Analysis Studies, and other validation workAuthoring/releasing of...
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San Jose, California, United States EnIn Systems Full time{"title": "Team Lead Validation Engineer", "description": "Job SummaryWe are seeking a highly skilled Team Lead Validation Engineer to join our team at EnIn Systems. As a key member of our engineering team, you will be responsible for leading the development and implementation of validation strategies and processes for our medical device products.Key...
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Principal Validation Engineer
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Hardware Validation Engineer
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Lead Validation Engineer
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San Jose, United States Katalyst HealthCares & Life Sciences Full timeResponsibilities: The experience I am looking for is as follows. years relevant experience in medical device manufacturing. Clean room environment experience. Experience with Test Method Validation and/or Measurement System Analysis is preferred. Knowledge of computer software for the analysis of data, specifically Microsoft Excel and...
Validation Engineer
4 months ago
RoleThe Validation Engineer will be responsible for completing the commissioning and qualification activities for the equipment and systems included in a new Sterility Suite at one of our clients. The Sterility Suite will be created as part of a facility upgrade project to reconfigure an existing space into a new Grade D clean suite. The qualification will include commissioning qualification and validation (CQV) of the new suite and the Environmental Monitoring PQ (EMPQ) of the space. The project also includes CQV of the following equipment and systems· Air Handling Unit - Commissioning/IOQ/Integration with Building Automation System (BAS)· 2 Isolators - Commissioning/IOQ/EMPQ/Vaporized Hydrogen Peroxide (VHP) PQ· 4 Incubators - Commissioning/IOQ· 1 Refrigerator - Commissioning/IOQEstimated duration of the project is 6 months for a team of 2 resources with most of the work being completed onsite at the client’s facility in Southern California.Responsibilities· Generate and route for approval the Commissioning & Qualification Protocols for the equipment/system.· Generate and route for approval the test cases required for the equipment/system.· Support the execution resolution