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.
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.
The Clinical Diagnostic Division (CDD):
The Clinical Diagnostics Division (CDD) is an organization made up of business units which develop, manufacture and market instruments and consumables that serve a broad, diverse mix of diagnostic segments. The major business units include Niche Diagnostics, Biomarkers, Clinical Diagnostics Systems, and Contract Manufacturing. The division manages a diverse portfolio of products servicing multiple end markets. CDD maintains recognized technology and manufacturing leadership in the markets in which it serves. CDD has approximately $750M in revenue and 2,000 employees worldwide.
- 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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