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Job ID :
52255BR
Location :
US - California - Fremont
:
Job Description

When you’re 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.


Position Summary:

Supervise a team of validation engineers in support of facility, equipment and process validation activities.

Key Responsibilities:

  • Maintain the validation project schedule. Assign validation projects and track timelines to assure milestone deadlines are met.
  • Develop and track key metrics of the validation program.
  • Provide updates to department manager. Escalate issues and provide recommendations for resolution.
  • Mentor validation staff, including developing and tracking training plans.
  • Conduct annual and mid-year reviews, as well as regularly scheduled 1-on-1 meetings to provide timely feedback on performance issues.
  • Stay up-to-date on all regulatory requirements and best industry practices for implementing an effective validation program.
  • Assess validation/revalidation requirements for all new equipment and processes.
  • Assess the revalidation requirements for any equipment modifications or process changes.
  • Maintain the Facility Master Validation Plan.
  • Maintain the facility equipment list to document the validation lifecycle of all equipment.
  • Provide input to the Facilities Department on setting appropriate calibration tolerances and frequency of calibration.
  • Maintain and ensure systems and procedures are compliant with regulatory requirements and Thermo Fisher Scientific policies and procedures.

Minimum Requirements/Qualifications:

  • Bachelor Degree in a field of science. Engineering degree is preferred.
  • 10 years of experience in the regulated industry. In-vitro diagnostic experience preferred.
  • 5 years of supervisory experience in facility/utility, equipment or process validation.
  • Good understanding of QSR and ISO 13485 requirements relating to product realization and process validation.
  • Good analytical skills and ability to communicate effectively with all levels.
  • Proficient in Microsoft Word and Excel.
  • Good understanding of statistical techniques is a plus.

At Thermo Fisher Scientific, each one of our 50,000 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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