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Validation Lead

Company: USDM Life Sciences
Location: San Diego
Posted on: May 18, 2018

Job Description:

USDM Life Sciences is a leading global consulting firm focused on life sciences, specializing in regulated business processes, with an emphasis on compliance and performance. We are seeking a Sr Validation Engineer generalist who has experience with SaaS (Veeva) and/or Argus.

Will also support and need to have experience with:

Develop system validation scripts based on software/hardware configuration for enterprise systems:



  • Work with facility Subject Matter Experts to document user requirements
  • Update application system User Requirements, Functional, and Design Specifications
  • Develop Installation Qualifications based on Design
  • Develop Operation Qualifications based on functional requirements
  • Develop Performance Qualification scripts based on configuration
  • Route validation documentation
  • Manage Tasks based on aggressive timelines
  • Interact with customers at multiple sites
  • Interact in team environment


    Qualifications



    • Minimum BA / BS or relevant work experience in information systems,


      engineering, science or business.



      • Validation experience with computerized systems in the pharmaceutical industry.
      • Excellent oral and written communication skills.
      • Strong technical background --- familiar with writing queries
      • Thorough understanding of the principles of computer systems validation, SDLC methodologies and testing best practice.
      • Knowledge of cGMP, GDP, GAMP, 21CFR Part11 and industry best practices.
      • Ability to understand existing and new business processes and requirements to ensure proper implementation and validation of systems.
      • Strong communication and interpersonal skills ensuring the ability to interact with the business, peers and vendors in a professional manner.
      • Ability to work independently with minimal supervision.
      • Adhere to timelines
      • Quick learner
      • Expert in MS Word
      • Able to multitask

        Keywords: USDM Life Sciences, San Diego, Validation Lead, Other, San Diego, California

        Click here to apply!

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