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Process Engineer

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Location: Durham, United States
Position Type: Unfixed Term
Job Function: Manufacturing

A world leader in the field of in vitro diagnostics for over 55 years, bioMérieux provides diagnostic solutions that detect disease and contamination to improve patient health and ensure consumer safety. In North America we have more than 5,000 team members across 12 sites or subsidiaries, including Salt Lake City based BioFire Diagnostics. We believe in the power of diagnostics and bioMérieux sponsors public health initiatives and partnerships to address antimicrobial resistance, sepsis awareness, food safety, and consumer health across the globe. Come be a part of our mission to help save lives.

 

Position Summary:

This is a problem solving position. Provides technical knowledge, critical thinking, and expertise to assist in the resolution of problems in support of manufacturing, product release, compliance, and process improvement. 

 

Typical project work will include one or more of the following: 

  1.  Assist in the preparation and execution of scientific studies to support root cause determination, product impact, or process improvement activates.
  2.  Analyze data on product performance characteristics to aid in solving product and process related problems.
  3.  Preparing protocols using sound scientific  rationale, perform data analysis,  and author technical reports.
  4.  Support site compliance activities to include audits.  

This position involves support of multiple sites. Up to 25% domestic travel may be required under normal circumstances; travel restricted during pandemic.

The industry is highly regulated and compliance with FDA, ISO, IVD, Medical Device and other pertinent regulations and directives is required.

 

The Process Engineer position supports manufacturing operation and quality release by providing technical knowledge of the product and process and potential impact to non-conformities. This position will require support for the site compliance and quality programs. 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.

 

Main Accountabilities:

  • Execute scientific studies with guidance to support a variety of efforts.
  • Support technical investigations and implementation of 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 and scientific manner.
  • Perform a variety of testing using analytical chemistry and/or microbiological methods and instruments using cGMP standards for data collection and documentation.
  • Assist in the analysis of process and product performance data to identify trends to predict potential failures and to aid in solving product and process problems.
  • Become a site subject matter expert on products manufactured at the bioMerieux Durham site.

 

Studies, Experience, Skills and Qualifications:

  • BS degree in a technical field with experience, knowledge and skills to perform the position’s responsibilities. 
  • Oral and technical writing skills are required.
  • Up to 25% domestic travel may be required under normal circumstances; travel restricted during pandemic.
  • The following are essential to success in the process engineer role:
    • Minimum five years’ experience in a relevant industry
    • Strong  hands on laboratory skills
    • Demonstrated ability to communicate at all levels of the department
    • Demonstrated ability to work in a team environment
    • Ability to work productively and effectively with adequate supervision

 

Joining bioMérieux, is choosing to join an innovative company with a long term vision, committed to the service of public health and carried out with a humanistic corporate culture. Our Group offers numerous possibilities: so come and join the 13,000 bioMérieux team members who already identify with these values!

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

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