As the world’s leader in serving science, Thermo Fisher Scientific is a driving force in the research, healthcare, industrial and applied markets, generating more than $18B in annual revenue. No other company can match our range of customer touch points – technologically, geographically or commercially. We help our customers in finding cures for cancer, protecting the environment, making sure our food is safe and moving forward with thousands of important projects that improve millions of lives.
We are located at a newly constructed state-of-the-art manufacturing facility located in Fremont, CA. Our facility includes an onsite gym, cafeteria (with visiting chef), open concept work environment (fostering collaboration), electric vehicle charging stations, easy access to the Warm Springs BART station, and so much more.
THIS POSITION IS NOT ELIGIBLE FOR RELOCATION ASSISTANCE.
This position is a Validation Engineer II with focus on Revalidation and Periodic Review.
This role provides the opportunity to provide manufacturing and validation engineering support to the Clinical Diagnostics Group by performing scheduled revalidation and periodic reviews of the existing facility/utilities, equipment, processes and computer systems. This role is responsible for generating, executing and maintaining the revalidation and periodic review schedule. The position will review data collected from quality records to assess the state of control and the need for revalidation.
- Perform all scheduled revalidation of equipment per defined schedule.
- Review the current periodic review program and suggest improvements accordingly to current regulations.
- Update and maintain periodic review program schedule based upon risk for executing review process and cycle.
- Collation and interpretation of related information gathered into a report format.
- The extraction of data from a number of source systems.
- Collation and analysis of data using statistical analysis tools.
- Lead review meetings and communicating the output to a cross-matrix team.
- Generate, execute and report on periodic review for the assessment of facilities/utilities/equipment, validation of manufacturing processes and computer systems.
- Provide project updates to supervisor/manager. Escalate issues and provide recommendations for resolution.
- Assess the revalidation/requalification requirements resulting from periodic review.
- Support and provide requested documentation for internal and external audits/inspections. Ensuring function maintains audit readiness and completes regulatory audit actions in a timely manner
- Bachelor Degree in biological sciences, microbiology, chemistry or engineering.
- 2 plus years of experience in Quality Assurance and Validation
- Experience with ISO 13485 and FDA 820 requirements
- Experience with facility/utility/equipment qualification, process validation and computer systems validation
- Graduate Degree preferred
- DOE and process control project experience preferred
- Chemical process laboratory experience preferred
- Root cause analysis/problem solving experience preferred
- In-vitro diagnostic experience preferred.
- Expertise in process controls preferred
- Demonstrated success working in a complex, ideally global, matrix organization.
- Familiar with setting up standard procedures and processes, experience in lean management a plus.
- Detail oriented and efficient, with the ability to redirect focus quickly and effectively.
- Strong communication skills (verbal and written) strongly preferred
- Prudent and practical decision-making abilities, a team player, and can work independently without direct supervision.
- Proficient in Microsoft Office programs
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