BioFire Diagnostics
The Validation Specialist II develops and maintains validation programs to ensure manufacturing processes, equipment, and software systems comply with regulatory requirements and company standards. This role independently plans and executes validation activities, supports continuous improvement initiatives, and collaborates cross-functionally to maintain a validated state across operations. The position involves preparing validation documentation, investigating deviations, and ensuring compliance with cGMP, ISO 13485, and FDA guidelines.
Headquarters
Salt Lake City, Utah, United States
Company Size
1001-5000 employees
Founded
1990
BioFire Diagnostics, now operating as a product franchise brand under bioMérieux, is the leader in syndromic infectious disease diagnostics. Its flagship BIOFIRE® FILMARRAY® System delivers rapid, multiplex PCR results in approximately one hour, with FDA-cleared panels covering respiratory, gastrointestinal, blood culture, meningitis/encephalitis, pneumonia, and joint infection pathogens. The BIOFIRE System is designed for minimal hands-on time and is widely used in hospitals and clinical labs to support faster diagnoses, antimicrobial stewardship, and infection control.
Headquarters
San Francisco, CA
Company Size
201-500 employees
Founded
2018
Industry
Technology
Glassdoor Rating
4.2 / 5
Sarah Johnson
Chief Executive Officer
Michael Chen
Chief Technology Officer
Emily Williams
VP of Engineering
David Rodriguez
VP of Product
Jessica Thompson
Chief Financial Officer
Andrew Park
VP of Sales
View leadership team, funding history,
and employee contacts for BioFire Diagnostics.