Talent.com
Validation Engineer / CSV Engineer

Validation Engineer / CSV Engineer

Katalyst Healthcares & Life SciencesWalnut Creek, CA, US
30+ days ago
Job type
  • Full-time
Job description

Job Description

Job Description

Company Description

  • Katalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for contract research in Clinical trials of drugs, biologics and medical devices.
  • We have a few immediate job opportunities available in Drug Safety and Pharmacovigilance and Clinical Research field. We work with University hospitals, pharmaceutical companies and recruiting partners.

Job Description

Responsibilities :

  • Develop, implement, and maintain software quality assurance processes for non-product software used in medical device development.
  • Ensure adherence to regulatory standards (FDA, ISO 13485, IEC 62304) and industry best practices for non-product software.
  • Support audits and inspections by regulatory bodies, ensuring that non-product software systems comply with quality and documentation standards.
  • Ensure computerized systems are appropriately validated Assessment of applicability & criticality of GxP and 21 CFR Part 11.
  • Creation and review of validation deliverables including but not limited to Requirement Specifications (User, Functional Plan.)
  • Qualification Protocol (Installation, Operational, Performance) Reports (Summary, Exception) of protocol execution.
  • Traceability Matrix.
  • Periodic Reviews.
  • System Retirement / Decommissioning.
  • Execution of Dry / Test protocol run.
  • Conduct Periodic Reviews to determine if system is in a validated state and take appropriate actions.
  • Perform System Retirement / Decommissioning of systems not in business.
  • Work closely with software development and IT teams to establish best practices for quality and compliance.
  • Provide expertise and guidance on quality assurance processes for non-product software to ensure robust software management.
  • Drive continuous improvement initiatives in software development processes, ensuring alignment with the company's quality management system.
  • Requirements :

  • A Minimum bachelor's degree in engineering, Science or related technical field.
  • Minimum of 4-5 years of experience in software quality assurance or software validation, preferably within the medical device industry.
  • Strong understanding of quality standards and regulatory requirements (e.g., FDA 21 CFR Part 820, ISO 13485, IEC 62304).
  • Experience with non-product software validation, including tools for development, testing, and maintenance.
  • Good knowledge and experience of CSV activities but not limited to.
  • GxP and 21 CFR Part 11 applicability / criticality assessment.
  • Identification, Preparation and Review of validation deliverables such as Requirements, Plan, Protocols, Test specifications, Reports, Traceability Matrix etc.
  • Execution of Dry / Test protocols.
  • Conduct Periodic Reviews of systems.
  • Perform System Retirement of systems that are not in business.
  • Understanding of Medical Device Quality and Compliance.
  • Good knowledge of GxP, GAMP and 21CFR Part 11 guidelines.
  • Working experience in Product Lifecycle Management (PLM) tool.
  • Sound knowledge of computer system development lifecycles.
  • Knowledge of JIRA, JAMA software and test automation is a plus.
  • Additional Information

    All your information will be kept confidential according to EEO guidelines.

    Create a job alert for this search

    Validation Engineer • Walnut Creek, CA, US

    Related jobs
    • Promoted
    Verification Validation Engineer, Medical Device (Sonoma)

    Verification Validation Engineer, Medical Device (Sonoma)

    SciProSonoma, CA, US
    Part-time
    This is not a software role • • •.The focus will be mechanical / medical device testing and V&V protocols through simulated use studies in partnership with surgeons. Design Verification & Validation : .P...Show moreLast updated: 6 days ago
    Identification Supervisor

    Identification Supervisor

    Alameda County Sheriff's Office - Recruiting UnitDublin, California, United States
    Full-time
    Quick Apply
    Deadline to Apply : 09 / 12 / 2025 5pm PST.Identification Supervisors are assigned to a shift or serve as the administrative IDS, performing related work as required. The classification of Identification...Show moreLast updated: 30+ days ago
    • Promoted
    Travel Cath Lab Technologist - $3,156 per week

    Travel Cath Lab Technologist - $3,156 per week

    LanceSoftNapa, CA, United States
    Full-time +1
    LanceSoft is seeking a travel Cath Lab Technologist for a travel job in Napa, California.Job Description & Requirements.Certs REQ : BCLS, ARRT, Flouro Permit, CA license. Min 1yr of experience requir...Show moreLast updated: 19 days ago
    • Promoted
    Senior R&D Engineer, Med Device

    Senior R&D Engineer, Med Device

    Eliassen GroupSonoma, CA, US
    Full-time
    BUSINESS PROBLEM, CONTEXT & INITIATIVE DESCRIPTION.Our client is a privately held medical device company based in Northern California growing rapidly in the development of disease-modifying the...Show moreLast updated: 10 days ago
    • Promoted
    Air Interdiction Agent

    Air Interdiction Agent

    U.S. Customs and Border ProtectionCourtland, CA, United States
    Full-time
    Pilot CBP Air Interdiction Agent.Air and Marine Operations (AMO), a component of U.Customs and Border Protection (CBP), offers skilled Pilots interested in law enforcement an opportunity to work wi...Show moreLast updated: 3 days ago
    • Promoted
    Sr. Design Engineer

    Sr. Design Engineer

    RIX INDUSTRIESBenicia, CA, United States
    Full-time
    RIX Industries is a technology-focused company specializing in the design, development and manufacturing of gas generation systems, precision compressor solutions, and cryogenic cooling technologie...Show moreLast updated: 30+ days ago
    • Promoted
    Mechanical Design Engineer II

    Mechanical Design Engineer II

    RIX INDUSTRIESBenicia, CA, United States
    Full-time
    RIX Industries is a technology-focused company specializing in the design, development and manufacturing of gas generation systems, precision compressor solutions, and cryogenic cooling technologie...Show moreLast updated: 30+ days ago
    • Promoted
    Verification Validation Engineer, Medical Device (San Francisco)

    Verification Validation Engineer, Medical Device (San Francisco)

    SciProSan Francisco, CA, US
    Part-time
    This is not a software role • • •.The focus will be mechanical / medical device testing and V&V protocols through simulated use studies in partnership with surgeons. Design Verification & Validation : .P...Show moreLast updated: 6 days ago
    • Promoted
    Travel Vascular Tech - $2,381 to $2,559 per week in Fairfield, CA

    Travel Vascular Tech - $2,381 to $2,559 per week in Fairfield, CA

    AlliedTravelCareersFairfield, CA, US
    Full-time
    AlliedTravelCareers is working with Host Healthcare to find a qualified Vascular Tech in Fairfield, California, 94533!.Host Healthcare is an award-winning travel healthcare company with an immediat...Show moreLast updated: 30+ days ago
    CQV Engineer

    CQV Engineer

    Intellectt INCSan Francisco, CA, United States
    Full-time
    Quick Apply
    MsoNoSpacing"> Job Title : CQV Engineer Location : San Francisco, CA / Vacaville, CA (Onsite) Show moreLast updated: 6 days ago
    • Promoted
    Verification Validation Engineer, Medical Device (Hayward)

    Verification Validation Engineer, Medical Device (Hayward)

    SciProHayward, CA, United States
    Full-time
    This is not a software role • • •.The focus will be mechanical / medical device testing and V&V protocols through simulated use studies in partnership with surgeons. Design Verification & Validation : .P...Show moreLast updated: 6 days ago
    • Promoted
    Sr. Design Engineer (Vallejo)

    Sr. Design Engineer (Vallejo)

    RIX IndustriesVallejo, CA, United States
    Full-time
    RIX Industries is a technology-focused company specializing in the design, development and manufacturing of gas generation systems, precision compressor solutions, and cryogenic cooling technologie...Show moreLast updated: 4 days ago
    • Promoted
    Travel Cath Lab Technologist - $3,336 per week

    Travel Cath Lab Technologist - $3,336 per week

    Healthcare SupportFairfield, CA, United States
    Permanent
    Healthcare Support is seeking a travel Cath Lab Technologist for a travel job in Fairfield, California.Job Description & Requirements. HealthCare Support is actively seeking a Cardiac Cath Lab Techn...Show moreLast updated: 30+ days ago
    • Promoted
    Verification Validation Engineer, Medical Device

    Verification Validation Engineer, Medical Device

    SciProHayward, CA, US
    Full-time
    This is not a software role • • •.The focus will be mechanical / medical device testing and V&V protocols through simulated use studies in partnership with surgeons. Design Verification & Valid...Show moreLast updated: 10 days ago
    • Promoted
    Verification Validation Engineer, Medical Device (San Francisco Bay Area)

    Verification Validation Engineer, Medical Device (San Francisco Bay Area)

    SciProSan Francisco Bay Area, US
    Part-time
    This is not a software role • • •.The focus will be mechanical / medical device testing and V&V protocols through simulated use studies in partnership with surgeons. Design Verification & Validation : .P...Show moreLast updated: 6 days ago
    • Promoted
    Verification Validation Engineer, Medical Device (Fremont)

    Verification Validation Engineer, Medical Device (Fremont)

    SciProFremont, CA, US
    Part-time
    This is not a software role • • •.The focus will be mechanical / medical device testing and V&V protocols through simulated use studies in partnership with surgeons. Design Verification & Validation : .P...Show moreLast updated: 6 days ago
    CAE Optimization Engineer (Mid-Level)

    CAE Optimization Engineer (Mid-Level)

    TekWissen LLCNewark, CA, United States
    Temporary
    Quick Apply
    Overview : TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions...Show moreLast updated: 6 days ago
    • Promoted
    Senior Quality Engineer (Hybrid)

    Senior Quality Engineer (Hybrid)

    iRhythm Technologies, Inc.San Francisco, CA, US
    Full-time
    Quality System Compliance activities, supporting equipment management, laboratory compliance and audit readiness at iRhythm Technologies. In this role, you will champion a quality culture mindset by...Show moreLast updated: 10 days ago
    • Promoted
    Air Quality Engineer / Scientist - Mid to Senior Level (Environmental Compliance Specialist)

    Air Quality Engineer / Scientist - Mid to Senior Level (Environmental Compliance Specialist)

    Yorke Engineering, LLCBerkeley, CA, US
    Full-time
    Join Yorke Engineering, LLC, an Environmental Consulting leader in California that implements Environmental Engineering and Compliance solutions for our clients throughout California.Our mission is...Show moreLast updated: 2 days ago
    • Promoted
    BIOPHARMACEUTICAL - C&Q ENGINEER

    BIOPHARMACEUTICAL - C&Q ENGINEER

    MMR ConsultingSonoma, CA, US
    Full-time
    MMR Consulting is an engineering and consulting firm specializing in the pharmaceutical and biotechnology industries.Its services include Engineering, Project Management, and other Consulting servi...Show moreLast updated: 8 days ago