Sr. CSV Engineer

1 week ago

California, United States Katalyst CRO Full time

Join to apply for the Sr. CSV Engineer role at Katalyst CRO 2 days ago Be among the first 25 applicants Responsibilities Responsible for preparing and executing test documentation for GMP computerized systems as well as providing support in the troubleshooting of issues during test execution. Coordinate with multi-disciplinary validation team and be responsible for the validation of automated equipment and control systems. Develop and modify validation documentation including User Requirements Specifications (URS), Design Reviews (DR), Criticality assessments, CSV protocols (SAT, IQ, OQ, PQ) which verify compliance with regulatory and client requirements, reports summarizing protocol results, exception reports identifying defects, and review of vendor documentation. Qualifications and Requirements A strong understanding of 21 CFR Part 11, ICH standards, EMA and FDA (GxP) regulations, and GAMP methodologies. MES expertise is required. Resource must work from Bothell location. Requirement Specification document review and approvals; System Implementation Summary Report Review; Review and Pre-Approve ST/UAT Test Scripts in ALM; Create, Update RRA (Regulatory Risk Assessment) and obtain approvals; Post Execution Review and Post Approvals in ALM; CR Implementation Approvals; Retirement Summary review. Deliverables Requirement document Validation/Test Plan Requirement Traceability Matrix Change Requests Test/Validation Summary Report Seniority level Mid-Senior level Employment type Full-time Job function Engineering and Information Technology Industries Civil Engineering #J-18808-Ljbffr

  • Senior CSV Engineer

    2 weeks ago

    California, United States iRhythm Technologies, Inc. Full time

    iRhythm Technologies, Inc. provided pay range This range is provided by iRhythm Technologies, Inc.. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more. Base pay range $112,000.00/yr - $145,000.00/yr About the Role: As a Senior Quality Engineer – Computer System Validation (CSV) , you’ll support...

  • Senior CSV Engineer — GxP Validation

    1 week ago

    California, United States Katalyst CRO Full time

    A leading clinical research organization in Oregon City is seeking a Sr. CSV Engineer for their team. This role involves preparing and executing test documentation for GMP computerized systems, coordinating with validation teams, and developing validation documents to ensure compliance with regulatory requirements. Candidates must have a strong understanding...

  • Manager, Computer System Validation

    4 weeks ago

    California, United States BridgeBio Full time

    Mavericks WantedWhen was the last time you achieved the impossible? If that thought feels overwhelming, you might want to pause here, but if it sparks excitementread onIn 2015, we pioneered a moneyball for biotech approach, pooling projects and promising early?stage research from academia together under one financial umbrella to reduce risk and unleash...

  • Manager, Computer System Validation

    3 weeks ago

    California, United States BridgeBio Full time

    Mavericks WantedWhen was the last time you achieved the impossible? If that thought feels overwhelming, you might want to pause here, but if it sparks excitementread onIn 2015, we pioneered a moneyball for biotech approach, pooling projects and promising early?stage research from academia together under one financial umbrella to reduce risk and unleash...

  • Manager, Computer System Validation

    2 weeks ago

    California, MO, United States BridgeBio Full time

    Mavericks WantedWhen was the last time you achieved the impossible? If that thought feels overwhelming, you might want to pause here, but if it sparks excitementread onIn 2015, we pioneered a moneyball for biotech approach, pooling projects and promising early?stage research from academia together under one financial umbrella to reduce risk and unleash...

  • Manager, Computer System Validation

    2 weeks ago

    California, MO, United States BridgeBio Full time

    Mavericks WantedWhen was the last time you achieved the impossible? If that thought feels overwhelming, you might want to pause here, but if it sparks excitementread onIn 2015, we pioneered a moneyball for biotech approach, pooling projects and promising early?stage research from academia together under one financial umbrella to reduce risk and unleash...

  • Manager, Computer System Validation

    2 weeks ago

    California, MO, United States BridgeBio Full time

    Mavericks WantedWhen was the last time you achieved the impossible? If that thought feels overwhelming, you might want to pause here, but if it sparks excitementread onIn 2015, we pioneered a moneyball for biotech approach, pooling projects and promising early?stage research from academia together under one financial umbrella to reduce risk and unleash...

  • Sr. Director, Cloud and Engineering

    2 weeks ago

    California, United States Deckers Brands Full time

    Sr. Director, Cloud and Engineering page is loaded## Sr. Director, Cloud and Engineeringremote type: Remotelocations: US - California Remotetime type: Full timeposted on: Posted Todayjob requisition id: 19377At Deckers Brands, Together, Every Step is a promise kept that every employee can bring their authentic self, is valued and supported, as a...

  • Principal or Sr. Principal Field Engineer

    2 weeks ago

    California, United States Northrop Grumman Corp. (AU) Full time

    RELOCATION ASSISTANCE: Relocation assistance may be available CLEARANCE TYPE: Secret TRAVEL: Yes, 10% of the Time Description At Northrop Grumman, our employees have incredible opportunities to work on revolutionary systems that impact people's lives around the world today, and for generations to come. Our pioneering and inventive spirit has enabled us to be...

  • Sr. Embedded Software/Firmware Engineer/Contractor

    1 week ago

    California, United States A2e Technologies Full time

    OverviewTitle: Sr. Embedded Software/Firmware Engineer/ContractorLocation: San Diego (92121)Term: Long Term ContractDuration: Long TermStart: ImmediatelyResponsibilitiesSeeking Client facing Sr. Embedded Software/Firmware Engineer for a Hybrid role.Contractor with a Can Do approach with the ability to come up to speed quickly technically.Very collaborative...