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This Product Design Engineer must have the technical expertise to develop and lead product design projects, supervise product validation testing, drive to root cause for quality and reliability issues, interpret technical agency standards, and conduct projects in accordance with standard engineering practices.
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Feel like you're on the path to becoming a Sr. Validation Engineer but you're not quite there yet? As a Sr. Validation Engineer, you will build a meaningful and fulfilling career with the support of professional development resources and mentorships including our First Year Experience program, Individual Development Plans, and Career Path resources and tools.
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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.
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Work on new OEM (Original Equipment Manufacturer) custom HV DC (100kV Plus) X-Ray tube power sources to fulfill hi-tech customer requirements from design, verification, validation of specification, testing and documentation.
$75,000 - $120,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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The Electrical Engineer is responsible for the design, integration, and validation of Automated Test Systems. Chroma Systems Solutions, Inc. is a leading designer and manufacturer of power testing instruments and systems including programmable AC Power Source and DC Power Supplies, AC loads and DC Electronic Loads, Digital Power Meters and Automated Testing Systems for applications in LED Lighting, Led Drivers, Aerospace, Defense, Military, Automotive, Medical, Battery, Solar, Marine, and Regulatory Testing purposes.
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Responsible for regulatory internal reporting, internal auditing and validation of compliance activities and reporting all relevant accidents and dangerous occurrences to the EHS Manager.
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Author, document, review quality record documentation including NC, RCI, FI and other areas of quality engineering/validation, spreadsheet validation, and equipment qualification. Partner with Manufacturing, Product Support, Microbiology, Regulatory Affairs, Quality Control Labs, Engineering and Compliance.
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Support for mechanical product validation testing and regulatory compliance. Seeking a Mechanical Engineer for design and development of electro-mechanical products in the Medical, Industrial, Commercial, and Natural Resources markets.
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S88 Batch GAMP5, System and Software Development Life Cycles methodologies, validation Relational databases such as SQL, Oracle Automation protocols such as HART, Foundation Fieldbus, Traditional I/O, Profibus, Ethernet I/P, OPC, Modbus TCP/IP, etc.
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General exposure and experience in a GMP/Validation discipline with a knowledge and understanding of pharmaceutical Design/Build/Commission/Validation processes and how they relate to regulatory requirements and cGMP regulations within the E.U. and U.S. FDA.
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The Validation Engineer is responsible for providing engineering support for maintenance and validation activities while managing regulatory requirements around methodology and protocols for pharmaceutical manufacturing.
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This includes activities related to, but not limited to, market feedback, product development, process development, working with vendors, field validation, field (jobsite) scale-up, commercialization testing and regulatory compliance.
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Bio Med, Quality, Pharma, Manufacturing process, Biomedical, continuous improvement, biologics, Medical Device, Manufacturing, GD T, QMS, ASQ, Six Sigma, tissue, tissue processing, nerve, validation, cGMP, GMP, Regulatory, Ppap, Quality management, Capa, Audit, root cause analysis, Commissioning, Manufacturing engineering, Process engineering, Process improvement, CFR Part, fda compliance.
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Will supervise 7 employees: (Process Engineer 2, Principal Technical Writer 1, Validation Engineer 2, Group Leaders 2 ). Must have thorough knowledge of different regulatory guidance regarding process development, ICH guidelines, process validation, equipment facility and utility qualifications.
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Master’s Degree or foreignequivalent in Pharmacy/Regulatory Affairs/Chemistry or related + 1 yr ofexperience as Clinical Analyst, Regulatory Affairs Associate, QA Engineer orrelated, developing/creating Test Plan, and using software validation lifecycle and EDC applications (Medrio, RAVE and Inform) is required.
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