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In depth knowledge of regulatory requirement and proven success in assay qualification and validation for a range of bioanalytical methods. A bioanalytical subject matter expert with a broad array of technical and scientific experience using a multitude of technology platforms, such as ligand-binding assays (LBA), molecular assays, flow cytometry to assess pharmacokinetics, biodistribution, pharmacodynamic biomarkers and immunogenicity.
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Responsibilities could include, but are not limited to: site damage inspections, cost estimate and scope of work development, exploratory calls and recovery scoping meetings, project reviews and validation, review and determination of hazard mitigation requirements, and environmental & historic preservation reviews and guidance.
ExpandApply NowActive JobUpdated 6 days ago - UpvoteDownvoteShare Job
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Experience in software design, development, verification, validation and testing activities for embedded software. Lead quality focused design and development of software within the software development lifecycle (Agile/waterfall/ SAFe/DevOps) by defining the requirements, design, verification and validation plan and strategies while maintaining traceability.
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Works out the details of functional and design requirements, systems design, programming specifications, data elements, data validation specifications, data capture mechanisms, and data conversion procedures through discussions with Government staff and own superiors.
$201,898 a yearFull-timeExpandApply NowActive JobUpdated 7 days ago - UpvoteDownvoteShare Job
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As a System Validation Engineer at Zoox, you will be working as part of a multidisciplinary team to develop and test systems that enable and support our robotaxi, including the safety of closures, body, thermal, and lighting systems.
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Requirements include: Position Requirements: BS in a Computer Science or Engineering field or equivalent experience 3+ years experience with Computer systems validation Experience with GAMP and 483, compliance, consent decree experience, deep 21CFR Part 11 experience is preferred Experience in biotech and pharma is preferred over medical device Experience with Rockwell Pharmasuite, Emerson Syncade, MES, Delta V, PI is a plus.
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Creates and maintains study data management documents according to instructions (e.g. Data Management Handbook, Data Management Plan, Data Validation Plan, EDC System User's Guide, EDC Training and Certification Documents.
Full-timeExpandApply NowActive JobUpdated 3 days ago - UpvoteDownvoteShare Job
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Under moderate direction from Field Service mentors and leadership, complete troubleshooting, installation, validation, preventative maintenance, modifications, and service repair needs on Beckman Coulter equipment including providing excellent and efficient service to Beckman Coulter's customers, along with technical training on products.
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The qualified candidate will be responsible for bioinformatics pipeline development, database curation and construction and validation of microbiome tests as part of Psomagen’s microbiome testing business.
Full-timeExpandApply NowActive JobUpdated 13 days ago - UpvoteDownvoteShare Job
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Assay development, validation and analysis of PK and PD samples. Design and execute analytical testing to assess antibody function, with a focus on flow cytometry, ELISA, and other cell-based assays.
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Train and assist internal customers and stakeholders with the creation, design, configuration, validation, installation, commissioning and operation of BMS and EPMS systems. 10+ years of experience with industrial controls in critical environment (data center, pharmaceutical, manufacturing, oil & gas, petrochemical, laboratory, power, water etc.
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Hands-on experience with build, test, and release methods; such as compilers, linting (Eslint), CI/CD tooling, software testing and validation techniques (Jest, React Testing Library, Chromatic, Rollup), and modern dev-ops practices.
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Experience with analytical method validation, formulation and biopharmaceutical development, characterization, control strategy, quality risk management, and/or CMC regulatory guidance and BLA filings is desired.
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Own custom PCB from start to finish: specification, architecture, circuit design, schematic, layout, prototype, validation, and manufacturing support. Own custom PCB from start to finish: specification, architecture, circuit design, schematic, layout, prototype, validation, and manufacturing support.
$85,000 a yearFull-timeExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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Direct experience with and knowledge of the requirements for tech transfer of drug substance and drug product manufacturing processes and analytical method development and validation. Acts as the primary interface with Quality Assurance on matters related to CMC and methods development and validation.
Full-timeExpandApply NowActive JobUpdated 10 days ago
validation job in Potomac, MD
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