Talent.com
Validation PM

Validation PM

RxCloudFoster City, CA, United States
2 days ago
Job type
  • Full-time
Job description

About the job Validation PM

As a Validation Project Manager, you will be responsible for one or more projects within the Validation Group. You will coordinate the validation project team and ensure that we plan, prepare, execute, and evaluate all required tests during cell development.

A Validation Manager oversees and validates manufacturing plants' daily operations, ensuring compliance with standards and regulations. They often inspect information technology systems and machinery, review specifications and documentation, gather and analyse feedback, and observe various areas' maintenance procedures. It is also their responsibility to manage validation teams, supervising them while implementing policies and regulations. Moreover, a Validation Manager develops validation plans for various facilities and produces detailed reports, along with recommendations and conclusions.

Essential Duties and Responsibilities :

  • Act as a single validation contact point to assigned validation project(s)
  • Collaborate with stakeholders to define project scope, goals, dependencies, and deliverables.
  • Collect and review requirements to ensure product eligibility for system compatibility testing.
  • Responsible for cross-functional team communication and weekly status monitoring of project(s)
  • Work with related teams to maintain system qualified component list (QCL) during product development stage.
  • Collaborate with internal teams for continuous process improvement and software tool enhancements.
  • Continual knowledge development of current and new server products and technology

Qualifications :

  • B.E. in electrical or computer related engineering field is preferred.
  • Minimum 5 years of experience in project management
  • Minimum 3 years of experience in servers / computer industry is preferred.
  • Knowledge of product development processes including waterfall and agile method is preferred.
  • Strong interpersonal skills with ability to collaborate and delegate with cross-functional teams.
  • Self-motivated and proactive with problem-solving skills and critical thinking capabilities
  • Proficiency in presentation and spreadsheet software
  • Validation Manager Responsibilities

  • Manage the CSV project
  • Implement a regression process, and manage the execution of the regression testing.
  • Manage an SSD validation team responsible for testing and debugging the next generation PCIe SSD's.
  • Manage QA disposition and review of commercial stability material and conduct investigations on out-of-specification / anomalous results.
  • Coordinate site training requirements, deliver GMP and technical specific training, create and manage associated metrics.
  • Perform computer and control system validation for QC analytical instrumentation and manufacturing process systems.
  • Automate projects with PLC, DCS & MMI.
  • Revise and approve all commissioning books for GMP and Non-GMP systems.
  • Review IQ / OQ / PQ protocols and reports for accuracy, thoroughness and relevancy to the subject matter.
  • Serve as validation liaison during FDA and EU regulatory inspections; authorize all validation protocols and process changes.
  • Investigate manufacturing and validation deviations, recommend corrective & preventative actions (CAPA), & prepare related technical reports.
  • Identify and assign CAPA responsibilities.
  • Participate in QA review of RIBC department validation documents
  • Participate in FDA regulatory audits and present validation updates.
  • Create a job alert for this search

    Validation • Foster City, CA, United States

    Related jobs
    • Promoted
    Application Validation Engineer

    Application Validation Engineer

    SupermicroSan Jose, CA, United States
    Full-time
    Supermicro is a Top Tier provider of advanced server, storage, and networking solutions for Data Center, Cloud Computing, Enterprise IT, Hadoop / Big Data, Hyperscale, HPC and IoT / Embedded customers...Show moreLast updated: 30+ days ago
    • Promoted
    System Validation Engineer

    System Validation Engineer

    SupermicroSan Jose, CA, United States
    Full-time
    Supermicro is a Top Tier provider of advanced server, storage, and networking solutions for Data Center, Cloud Computing, Enterprise IT, Hadoop / Big Data, Hyperscale, HPC and IoT / Embedded customers...Show moreLast updated: 30+ days ago
    • Promoted
    Hardware Validation Engineer

    Hardware Validation Engineer

    SupermicroSan Jose, CA, United States
    Full-time
    Supermicro is a Top Tier provider of advanced server, storage, and networking solutions for Data Center, Cloud Computing, Enterprise IT, Hadoop / Big Data, Hyperscale, HPC and IoT / Embedded customers...Show moreLast updated: 30+ days ago
    • Promoted
    MES Validation Engineer

    MES Validation Engineer

    ValspecSan Francisco, CA, US
    Full-time
    Valspec—a global provider of system validation and lifecycle services—provides commissioning and qualification of computerized systems for clients in the Life Sciences industry.Establis...Show moreLast updated: 30+ days ago
    • Promoted
    Principal Systems Validation Engineer

    Principal Systems Validation Engineer

    Hayden AISan Francisco, CA, United States
    Full-time
    At Hayden AI, we are on a mission to harness the power of computer vision to transform the way transit systems and other government agencies address real-world challenges.From bus lane and bus stop...Show moreLast updated: 1 day ago
    • Promoted
    Project / Validation Engineer

    Project / Validation Engineer

    Project FarmaSan Francisco, CA, United States
    Full-time
    Welcome to the forefront of innovation in patient-centered treatments.We are seeking a Project Engineer to join our high-performing organization in the life sciences space.As a leader within the li...Show moreLast updated: 1 day ago
    • Promoted
    Senior Manager, Process Validation

    Senior Manager, Process Validation

    VaxcyteSan Carlos, CA, United States
    Full-time
    Join our Mission to Protect Humankind!.Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, wh...Show moreLast updated: 2 days ago
    • Promoted
    Software Engineer - Validation Toolset

    Software Engineer - Validation Toolset

    Applied IntuitionSunnyvale, CA, United States
    Full-time
    Applied Intuition is the vehicle intelligence company that accelerates the global adoption of safe, AI-driven machines.Founded in 2017, Applied Intuition delivers the toolchain, Vehicle OS, and aut...Show moreLast updated: 2 days ago
    • Promoted
    Software Validation Engineer, Integration, AI Platforms

    Software Validation Engineer, Integration, AI Platforms

    TeslaPalo Alto, CA, United States
    Full-time
    Tesla is a leader in innovative technology, pioneering advancements in autonomous vehicles and humanoid robotics.Our cutting-edge AI platform powers some of the most advanced systems globally, incl...Show moreLast updated: 2 days ago
    • Promoted
    Validation Engineer, Cryogenic

    Validation Engineer, Cryogenic

    PsiQuantumMilpitas, CA, United States
    Full-time
    Quantum computing holds the promise of humanity's mastery over the natural world, but only if we can build a.PsiQuantum is on a mission to build the first real, useful quantum computers, capable of...Show moreLast updated: 30+ days ago
    • Promoted
    Senior Software Engineer - Validation Toolset

    Senior Software Engineer - Validation Toolset

    Applied IntuitionMountain View, CA, United States
    Full-time
    Applied Intuition is the vehicle intelligence company that accelerates the global adoption of safe, AI-driven machines.Founded in 2017, Applied Intuition delivers the toolchain, Vehicle OS, and aut...Show moreLast updated: 2 days ago
    • Promoted
    Principal Validation Manager

    Principal Validation Manager

    Microsoft CorporationMountain View, CA, United States
    Full-time
    OverviewMicrosoft Silicon, Cloud Hardware, and Infrastructure Engineering (SCHIE) is the team behind Microsoft's expanding Cloud Infrastructure and responsible for powering Microsoft's "Intelligent...Show moreLast updated: 2 days ago
    • Promoted
    SAP Validation Lead

    SAP Validation Lead

    Katalyst Healthcares and Life SciencesFoster City, CA, United States
    Full-time
    We are seeking an experienced SAP Validation Lead to drive Computer System Validation (CSV) efforts for SAP systems in a regulated environment. The ideal candidate will ensure SAP implementations an...Show moreLast updated: 2 days ago
    • Promoted
    Sr. Electro-Optical Systems Validation Engineer

    Sr. Electro-Optical Systems Validation Engineer

    PsiQuantumMilpitas, CA, United States
    Full-time
    Quantum computing holds the promise of humanity's mastery over the natural world, but only if we can build a.PsiQuantum is on a mission to build the first real, useful quantum computers, capable of...Show moreLast updated: 2 days ago
    • Promoted
    Platform Validation Engineer, Customer Platforms - Tech Lead / Principal

    Platform Validation Engineer, Customer Platforms - Tech Lead / Principal

    d-MatrixSanta Clara, CA, United States
    Full-time
    AI to power the transformation of technology.We are at the forefront of software and hardware innovation, pushing the boundaries of what is possible. We value humility and believe in direct communic...Show moreLast updated: 30+ days ago
    • Promoted
    Senior Project / Validation Engineer

    Senior Project / Validation Engineer

    Project FarmaSan Francisco, CA, United States
    Full-time
    Welcome to the forefront of innovation in cutting edge patient centered treatments! We are seeking the best and the brightest to join our high performing organization as a Project Engineer.As a lea...Show moreLast updated: 1 day ago
    • Promoted
    Principal Lab Validation Engineer

    Principal Lab Validation Engineer

    Astera LabsSan Jose, CA, United States
    Full-time
    Astera Labs (NASDAQ : ALAB)provides rack-scale AI infrastructure through purpose-built connectivity solutions grounded in open standards. By collaborating with hyperscalers and ecosystem partners, As...Show moreLast updated: 1 day ago
    • Promoted
    Validation

    Validation

    Kasmo GlobalSan Francisco, CA, United States
    Full-time
    A top pharmaceutical company in Glendale (Los Angeles) is looking for multiple Validation Engineers to support capital projects. Strong in writing and executing IQ / OQ protocols.Hands-on with centrif...Show moreLast updated: 2 days ago