Staff Process Engineer (Quality Engineer)

A world leader in the field of in vitro diagnostics for over 55 years, bioMérieux provides diagnostic solutions which determine the source of disease and contamination to improve patient health and ensure consumer safety.

In North America we have more than 5,000 team members across 11 sites or subsidiaries, including Salt Lake City-based BioFire Diagnostics and one subsidiary in Montreal, Canada.

Come and join a family-owned global company with a long-term vision, and a human-centered culture.

Position Summary:

This is a problem solving position. Provides technical knowledge, critical thinking, and expertise to lead the resolution of problems in support of manufacturing, product release, compliance, and process improvement. This role is a resource in solving a wide variety of problems encountered in the manufacturing arena and will interface heavily with key individuals in many departments. 

Responsibilities:

• Lead failure investigations and implements solutions (corrective and preventive actions) that solve manufacturing and product problems, follow-up on corrective and preventive actions to determine their effectiveness and suitability, and prepare written reports on these activities in a timely fashion.
• Lead the preparation and execution of scientific studies to support root cause determination, product impact, or process improvement activates.
• Lead data analysis on product performance characteristics to aid in solving product and process related problems.
• Preparing protocols using sound scientific  rationale, perform data analysis,  and author technical reports.
• Support site compliance activities to include audits. 
• This position is based in St. Louis but reports to Technical Services in Durham, NC. Up to 25% domestic travel may be required under normal circumstances.
• This position involves support of multiple sites.

Studies and Experience:

• Bachelor degree in a technical field
• Minimum five years process engineer or scientist experience in a regulated environment

Skills and Qualifications:

• Project leadership and oral and written communication skills are required.
• Demonstrated ability to solve complex technical problems
• Strong team building skills
• Demonstrated ability to communicate at all levels of the site organization
• Demonstrated ability to work in a team environment
• Ability to work productively and effectively with little supervision

Supplemental Data:

The Staff Process Engineer position supports the manufacturing operation by providing technical knowledge, critical thinking, and expertise to resolve problems in support of manufacturing, product release, compliance, and process improvement. Position also introduces improved control systems and processes used in the manufacture and testing of in vitro diagnostic disposables. This position will require support for the site compliance and quality programs. May lead and direct the work of others, and is expected to become a site subject matter expert on products and processes. A wide degree of creativity and latitude is expected. Duties will be carried out as member of a team committed to Total Quality Management philosophy, requiring interaction with personnel of other departments and divisions.  Work will be conducted in accordance with GMP and ISO rules and regulations.

bioMérieux is an Equal Opportunity, Affirmative Action Employer. M/F/Vet/Disability/Sexual Orientation/Gender Identity/GINA.