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Computer System Validation Specialist

Company: Thermo Fisher Scientific
Location: Pleasanton
Posted on: May 4, 2021

Job Description:

Job Title: Computer System Validation SpecialistRequisition ID: 150434BRWhen you're a part of the team at Thermo Fisher Scientific, you'll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you'll be supported in achieving your career goals.How will you make an impact?In this position, you will be directly involved in the technical project management and execution of computer system validation engagements in conjunction with the Global Service and Support teams. Efficiency, accuracy, a keen willingness to learn, and the ability to work effectively with multiple stakeholders in a multi-cultural and geographically distributed environment are essential to success in this job.What will you do?

  • Interact with external stakeholders at all levels including laboratory scientists, laboratory technicians, laboratory directors, IT, QA and regulatory staff and/or consultants.
  • Master the documentation and execution process behind Computer System Validation.
  • Practice continuous PPI thinking.
  • Identify opportunities in laboratory workflows and data integrity where the company can offer value-added services to speed production deployment of platforms, increase customer retention and prohibit competitive entry.
  • Develop and pilot value-added services and support product commercialization process for these services (PCP).
  • Work effectively in an FDA regulated and/or ISO compliant environment.
  • Identify areas for process improvement in the development, training and delivery of these services.
  • Additional and incidental work related to the primary duties may be required for company business needs from time to time.
  • Travel (-30-50%) will be required for customer onsite visits. (global)How will you get here?Education
    • Bachelors or Master's Degree in a Scientific or Computer Sciences disciplineExperience
      • Experience with product or service development.
      • Computer programming.
      • In-depth knowledge and experience with performing and/or developing Computer System Validations
      • Excellent communication (verbal and written), negotiation, presentation, and interpersonal skillsKnowledge, Skills, Abilities
        • Documentation management/generation in a Content Management System a plus
        • Working knowledge of statistical methods.
        • Working knowledge of global regulated markets (FDA, CLIA, CAP, CFDA, etc).
        • Experience with html and /or xml a plusAt Thermo Fisher Scientific, each one of our 75,000 extraordinary minds have a unique story to tell. Join us and contribute to our singular mission-enabling our customers to make the world healthier, cleaner and safer.Apply today! http://jobs.thermofisher.comThermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.

Keywords: Thermo Fisher Scientific, Pleasanton , Computer System Validation Specialist, Other , Pleasanton, California

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