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Associate Process Engineer - Technology Transfer

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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 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:

The Process Engineer position supports the manufacturing operation by assisting in the introduction of improved equipment, control systems and processes used in the manufacturing of in vitro diagnostic disposables.  This role is a resource in solving a wide variety of problems encountered in the manufacturing arena and will primarily support technology transfer projects.  


Main Accountabilities:

  • The transfer of products and processes from Research and Development to manufacturing and the transfer of products and processes from one manufacturing line or site to another
  • Designs and conducts statistically valid scientifically sound feasibility studies and process development projects, and prepare timely written updates and report of these activities.
  • Writing and execution of validation protocols as required by the change control and validation programs.
  • Analyzes process and product performance data to identify trends to predict potential failures and aid in solving product and process problems.
  • Conducts 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.


Studies/Experience, Skills and Qualifications:

  • Bachelor’s Degree in a science or engineering field with 0-3 years of work experience in related industry or equivalent.
  • Familiarity with relevant domestic and international regulations and industry standards (e.g. ISO, FDA, QSR).
  • Exhibits strong analytical, attention to detail and problem-solving skills.  
  • Must have strong verbal communication and technical writing skills. 
  • Demonstrates the ability to work well in a complex, diverse environment both independently and on a team.
  • PC skills, including proficiency in: Microsoft Excel, PowerPoint, Outlook and Word. Statistical software experience preferred.

 

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

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