30 days old

Senior Process Validation Engineer

Thermo Fisher Scientific
San Jose, California
  • Job Type
  • Job Status
    Full Time
  • Shift
    1st Shift

When you join us at Thermo Fisher Scientific, you’ll be part of a smart, driven team that shares your passion for exploration and discovery. With revenues of $20 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.


How will you make an impact?

As part of the San Jose Operations Engineering team, you will do the important work of validation for our medical device products/instruments manufactured at the site and advise/guide our key suppliers in their efforts to validate and provide evidence of our contracted products. This position may require up to 10% travel.


What will you do?

  • Coordinate and lead PFMEA activities.
  • Develop validation protocols and other documentation for scientific instrument manufacturing processes for the San Jose Site.
  • Create the validation packages for instruments manufactured in San Joe including acquisition of necessary data and summation into final validation reports.
  • Coordinate technical assessments on change controls, deviations and investigations, to identify requirements necessary to maintain validated status.
  • Manage validation-related quality system activities (CAPAs OFIs, SCARs) and use project management skills to coordinate those items to closure.
  • Participate on core development, operations strategy, and quality assurance project teams as the validation expert for scientific instruments.
  • Ensure the validation process is kept maintained, up-to-date and within regulatory guidelines.
  • Provide guidance and support to San Jose key suppliers on the application and implementation of requirements for validation.
  • Report status of validation activities in the visual factory as well as in presentation formats.


How will you get here?


  • Bachelor’s degree in Engineering or Sciences, or equivalent work experience required
  • Minimum of 5 years validation experience
  • Possess excellent communication and interpersonal skills in a team environment
  • Demonstrated ability to lead projects, prioritize, and effectively achieve results through delegation
  • Demonstrate Thermo Fisher Scientific values – Integrity, Intensity, Innovation and Involvement
  • Solid computer skills using MS Office, Photoshop, Adobe, Visio or other related software used to create flowcharts, various related file management software, Outlook and the internet


At Thermo Fisher Scientific, each one of our 65,000 extraordinary minds has 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.com

Thermo 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.


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Senior Process Validation Engineer

Thermo Fisher Scientific
San Jose, California

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San Jose, California

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