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A Validation Engineer II is responsible for reviewing engineering design documentation, developing testing methodologies, authoring commissioning, qualification, and validation testing protocols, performing (executing) field testing, and authoring final reports for completed testing.
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Self-reliant definition of Validation Strategy in accordance with regulatory and customer requirements following risk-based approach (documentation in VMP and CRS/PRS) Self-reliant surveillance of validation activities in accordance with validation master plan, Product Specifications (e.g. CRS) and qualification / validation plans.
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In this role, you will be responsible for the validation strategy and SDLC documentation for Werum PAS-X MES and Fill/Finish systems, encompassing PLCs, SCADA, MES, and Serialization, within the life sciences manufacturing environment.
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Hardware development steps including concept, architecture, part selection, schematic/layout, bring-up, FPGA coding, Python coding, validation, and documentation. All aspects of printed circuit board (PCB) design.
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Analog design experience in verification, documentation, and post-silicon validation. onsemi’s Core-Analog IP Center of Excellence is hiring an experienced Analog IC design engineer to help us develop IP for next generation Automotive, Industrial & Medical products.
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The Engineer/Planner will work to assemble and prepare data for model validation and long-range future year travel forecasts; conduct model validation to required accuracy standards; develop traffic forecasts for toll road projects; and prepare the documentation of results.
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Responsible for all aspects of product design including - systems architecture, electrical engineering design, component selection, embedded systems / microprocessor based design and programing, requirements documentation, design verification, design validation, regulatory compliance, test plan creation, test tools and test scripts development, DFM/DFT, design reviews, and DFMEA. Lead projects ranging from short-term technology investigations to full-scale product development.
$150 - $200ExpandApply NowActive JobUpdated 0 days ago - UpvoteDownvoteShare Job
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Validation, IQ, OQ, PQ, Engineering, automation, pharma, commissioning, qualification, Quality control, quality assurance, technical documentation, document control, workflow, files, document management, auditing, engineering, pharma, pharmaceutical, contract to hire, contract, permanent, full time, benefits, 401K, direct hire, cell culture, gene therapy, temperature mapping, lab equipment, KAYE, Fill/finish, sterile, upstream, downstream, process.
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In this role, you will create specifications and design documentation for firmware and software applications and tools, interact with Engineering, Production, and Field Service departments for product development, testing and validation based on customer specifications.
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Support program team in product development activities including internal design reviews and gate reviews, weekly PDT meetings with customers, design/process validation planning, PPAP preparation, and documentation, etc.
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Maintenance of GLS software products to include creating requirements, composing supporting documentation, developing code, developing unit tests, participating in code peer reviews, writing, and executing test procedures for verification and validation tests, and data review.
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As a member of the Body team, the Body Design Release engineer will be responsible for the design execution and validation release of the Body and associated parts. The Body Design and Release Engineer ensures the compliance of the design with all BIW and vehicle attributes, technical and structural requirements, quality objectives, program milestones, deliverables and specific targets, subsystem technical specifications, cost, weight, timing and regulatory requirements.
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Perform component selection, design analysis, schematic capture, circuit board design, prototyping, board bring up, debugging, circuit validation, and design documentation for electrical designs.
$95,000 - $110,000 a yearFull-timeExpandApply NowActive JobUpdated 1 days ago - UpvoteDownvoteShare Job
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Good understanding of cGMPs and good documentation practices in order to prepare system life cycle technical documents such as URS, FRS,VMP, protocol generation and execution to support FAT, SAT, commissioning, qualification (IQ, OQ), SOPs, Validation (PQ, DS, CV, PV), FMEA and Validation Master Plan.
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Responsibilities will include developing technical documentation and plans, assessing new technologies and tools, circuit board design, firmware development, troubleshooting and repair, verification & validation, and testing.
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