Jobs
>
Austin

    Process Validation Engineer - Austin, United States - Katalyst Healthcares and Life Sciences

    Katalyst Healthcares and Life Sciences
    Katalyst Healthcares and Life Sciences Austin, United States

    19 hours ago

    Default job background
    Description

    Evaluate validation of the equipment, software and processes used in development and production of medical
    products ensuring all validations performed are adequate and compliant to the Regulatory and Flex SOP
    requirements.

    Principle Accountabilities:

    • Defines validation strategy and requirements and ensure implementation.
    • Review and approve validation requirements, master validation plan/report, validation protocols/ reports to
    • support Process Validation and re-validation activities for New Product Introduction and Sustaining in
    • accordance with FDA/AAMI/ISO/EN guidelines/standards.
    • Actively participate during all phases of process qualification.
    • Evaluate projects, provides guidance and technical information to others to generate protocols, execute.
    • qualification activities, analyze resulting data and to prepare reports.
    • Lead and assist in all assigned qualification activities.
    • Determine and establish requirements for qualification activities.
    • Make independent decisions related to qualification activities.
    • Participate in the generation and/or update of the validation plan and validation status lists.
    • Review qualification packages for completeness and accuracy, sound rationale, compliance with validation
    • policies and procedures, and accurate data analysis.
    • Compare results against acceptance criteria and work with appropriate departments to resolve exceptions and deviations.
    • Bring critical exceptions or deviations to management's attention and propose compliant solutions.
    • Lead trouble shooting activities for deviations and non-conformances.
    • Recommend to management as to the acceptance and release of qualified systems.
    • Initiate and enforce necessary improvements and corrections; attend team meetings pertinent to validation.
    • Write and revise standard operating procedures describing validation principles and activities.
    • Provide training and guidance to applicable operators and technicians.
    • Initiate, execute, and track completion of Change Control requests.
    • Establish priorities and schedule activities to ensure timelines and milestones are met.
    • Participate in external audits of providers and labs.
    • Ensure all systems are running according to necessary specifications and operate within regulations to
    • ensure the production of quality products.
    • Responsible for establishing validation standards.
    • Coordinate with required personnel affected by validation testing.
    • Review and approve validation execution reports, and associated deviations.
    • Analyzes test results.
    • Reviews and prepares compliance reports.
    • Directs validation activities.
    • Resolves testing problems.
    • Adjusts or improvements to equipment and processes.
    • Creates databases to track validation activities.
    • Interprets customer requirements.
    • Develops validation schedules.
    • Conducts training and overseeing the work of validation technicians.
    • Keeps up to date on industry standards and regulations.
  • Protingent

    Validation Engineer

    3 weeks ago

    Protingent Austin, United States

    Protingent Staffing has an exciting contract opportunity for Validation Engineer with our client that is located in Austin, TX. Job Responsibilities: - Define, develop, and execute the Datacenter GPU pre-silicon and post-silicon PCBA validation test Validation Engineer, Validatio ...

  • Trilyon, Inc.

    Validation Engineer

    3 weeks ago

    Trilyon, Inc. Austin, United States

    Job Description · Job Description · Description: · Location: 100% onsite in Austin · TITLE: System Validation Engineer · DESCRIPTION: · The candidate will configure and maintain test hardware and infrastructure across multiple desktop systems and programs. · Must keep systems ...

  • Renesas Electronics

    Senior Validation Engineer

    5 days ago

    Renesas Electronics Austin, United States Full time

    · Job Description · This is an opportunity to contribute at a high level to the technical and commercial success of the corporation. To succeed, you will need to combine understanding of multiphase VR systems, automated testing equipment and software, and industry best practices ...

  • LanceSoft

    Power Validation Engineer

    8 hours ago

    LanceSoft Austin, United States

    : KEY RESPONSIBILITIES: · Define, develop, and execute the Datacenter GPU pre-silicon and post-silicon PCBA validation test plans and schedule with cross-functional engagement from the various design teams, program leads and, program managers. · Develop platform validation pla ...

  • Advanced Micro Devices , Inc.

    Lead Validation Engineer

    4 days ago

    Advanced Micro Devices , Inc. Austin, United States

    Overview: · WHAT YOU DO AT AMD CHANGES EVERYTHING · We care deeply about transforming lives with AMD technology to enrich our industry, our communities, and the world. Our mission is to build great products that accelerate next-generation computing experiences the building bloc ...

  • Ambiq Micro, Inc

    Staff Validation Engineer

    1 week ago

    Ambiq Micro, Inc Austin, United States

    Job Description · Job DescriptionDescription:Company Overview: · Ambiq's mission is to develop the lowest-power semiconductor solutions to enable intelligent devices everywhere by developing the lowest-power semiconductor solutions to drive a more energy-efficient, sustainable, a ...

  • Renesas Electronics

    Senior Validation Engineer

    2 days ago

    Renesas Electronics Austin, United States

    Job Description · Job DescriptionCompany Description · Renesas is one of the top global semiconductor companies in the world. We strive to develop a safer, healthier, greener, and smarter world, and our goal is to make every endpoint intelligent by offering product solutions in t ...

  • Tekwissen

    System Validation Engineer

    3 weeks ago

    Tekwissen Austin, United States

    Job Description · Job Description · Overview: · TekWissen Group is a workforce management provider throughout the USA and many other countries in the world. This Client is an American multinational semiconductor company based in Santa Clara, California, that develops computer ...

  • Apple

    Silicon Validation Engineer

    4 days ago

    Apple Austin, United States

    Silicon Validation Engineer · Austin,Texas,United States · Hardware · In this highly visible role, you will perform lab characterization and validation of various analog & mixed signal embedded circuits; and collaborate with multi-functional teams to launch the world's most pr ...

  • Oho Group Ltd

    Silicon Validation Engineer

    19 hours ago

    Oho Group Ltd Austin, United States

    Silicon Validation Engineer · We're looking for a Silicon Validation Engineer at an exciting RISC-V start-up · The Silicon Validation Engineer holds the responsibility for bringing up and validating the SOC subsystems within the SOC design. This role demands an extensive compre ...

  • Netwoven

    Validation Engineer

    3 weeks ago

    Netwoven Austin, United States

    KEY RESPONSIBILITIES: · Define, develop, and execute the Datacenter GPU pre-silicon and post-silicon PCBA validation test plans and schedule with cross-functional engagement from the various design teams, program leads and, program managers. · Develop platform validation plans an ...

  • TekWissen ®

    Validation Engineer

    3 weeks ago

    TekWissen ® Austin, United States

    Overview: · TekWissen Group is a workforce management provider throughout the USA and many other countries in the world. This Client is an American multinational semiconductor company based in Santa Clara, California, that develops computer processors and related technologies fo ...

  • Azzur Group

    Validation Engineer

    1 week ago

    Azzur Group Austin, United States

    Essential Duties and Responsibilities · Azzur personnel are expected to live up to our core values at all times and exhibit a high level of integrity and personal responsibility, especially when interacting with our valued clients. As a CQV Engineer at Azzur Group, you will play ...

  • LanceSoft

    Validation Engineer

    3 weeks ago

    LanceSoft Austin, United States

    : · • The candidate will configure and maintain test hardware and infrastructure across multiple desktop systems and programs. · • Must keep systems running, up to date, and keep hardware and validation infrastructure test-ready in all other ways, in support of client roadmap sch ...

  • Renesas Electronics

    Senior Staff Validation Engineer

    2 weeks ago

    Renesas Electronics Austin, United States Full time

    · Job Description · The Infrastructure Digital Power Applications team is seeking a Sr Staff Validation Engineer who is excited about working on cutting edge power solutions for server and infrastructure processor/SOC applications. You will be leading the validation efforts in ...

  • Saicon Consultants

    Validation Engineer

    2 weeks ago

    Saicon Consultants Austin, United States

    Validation Engineer (Intermediate) · Location:Austin, TX · Posted On: 03/14/2024 · Requirement Code: 67284 · Requirement Detail · KEY RESPONSIBILITIES: · • Define, develop, and execute the Datacenter GPU pre-silicon and post-silicon PCBA validation test plans and schedule with ...

  • Tekwissen

    Validation Engineer

    2 weeks ago

    Tekwissen Austin, United States

    Overview: · TekWissen Group is a workforce management provider throughout the USA and many other countries in the world. This Client is an American multinational semiconductor company based in Santa Clara, California, that develops computer processors and related technologies fo ...

  • Tekwissen

    Validation Engineer

    3 weeks ago

    Tekwissen Austin, United States

    Overview: · TekWissen Group is a workforce management provider throughout the USA and many other countries in the world. This Client is an American multinational semiconductor company based in Santa Clara, California, that develops computer processors and related technologies f ...

  • NXP Semiconductors

    ASIC Validation Debug Engineer

    1 day ago

    NXP Semiconductors Austin, United States

    As an ASIC Validation Debug Engineer, you will play a crucial role in the development and testing of NXP semiconductor products. You will be responsible for identifying and resolving issues in semiconductor designs, ensuring optimal functionality and performance. This role requir ...

  • LanceSoft, Inc.

    Validation Engineer

    4 weeks ago

    LanceSoft, Inc. Austin, United States

    Preferred Experience: · • Excellent understanding of the fundamentals of power electronics with special emphasis on multiphase power converters · • Demonstrated ability to work with oscilloscopes, multi-meters, current probes, electronic loads, and protocol analyzers as well as a ...