This role provides the opportunity to work with all areas of manufacturing supporting diverse projects. In addition, you will provide manufacturing, and validation engineering support to the Clinical Diagnostics business including facilities, utilities, and equipment used in manufacturing, and product testing. In the longer term, you will have the ability to support process improvment projects, and new capital equipment acquisitions.
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.
Generate, execute and report on protocols for the qualification of facilities/utilities/equipment and validation of manufacturing processes.
Assist in the development of user requirements for new equipment acquisitions.
Conduct risk assessments for equipment and processes.
Develop validation strategies based on regulatory requirements, scientific rationale, industry practice and assessed risk.
Perform P&ID and I/O verifications.
Participate in FAT, SAT, commissioning and startup of new equipment.
Provide project updates to supervisor/manager. Escalate issues and provide recommendations for resolution.
Assess the revalidation requirements for any equipment modifications or process changes.
Provide input to the Facilities Department on preventive maintenance and calibration requirements, including setting appropriate calibration tolerances and frequency of calibration.
Work with the Manufacturing and Quality departments to develop and train on standard operating procedures and work instructions.
Bachelor Degree in a field of science. Engineering degree is preferred.
5 years of experience in the cGMP regulated industry. In-vitro diagnostic experience preferred.
Demonstrated experience in facility/utility/equipment qualification and process validation.
Skilled in the setup and calibration of a Kaye Validator for temperature mapping studies.
Good understanding of 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.
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.