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Process Engineer

Location: Durham, United States
Position Type: Unfixed Term
Job Function: Project/Program Management

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:

As part of the Industrialization department, the Process Engineer will support manufacturing operations by developing and/or managing process improvement projects to support the manufacturing of the manufacturing of in vitro diagnostics. Within this role the Process Engineer will be required to interface with Manufacturing, Quality Control, Quality Assurance, R&D, Purchasing, Supply Chain, JSE. and other functions as required, in order to ensure successful project achievements to facilitate quality production that meets on-time customer demands. Duties will be carried out as a member of a team committed to Total Quality Management philosophy. Work will be conducted in accordance with GMP and ISO rules and regulations.

 

Responsibilities:

  • Support and/or manage multiple projects related to the manufacturing of in vitro diagnostics.
  • Guide timelines, adjust expectations, coordinate with colleagues, and collaborate cross-functionally to ensure successful project implementation.
  • Provide subject matter expertise (technical knowledge) when acting as departmental representation on cross-functional teams, as well as, participate and identify improvement opportunities and strategies.
  • Design and conduct statistically valid, scientifically sound feasibility studies and process development projects, and prepare timely written updates and report of these activities.
  • Write and execute validation protocols as required by the change control and validation programs.
  • Analyze process and product performance data to predict/prevent potential failures and aid in solving product/process challenges.
  • Analyze components (materials) to mitigate manufacturing risk and/or cost saving initiatives.
  • Support investigations and implementation of solutions (corrective and preventative actions) to solve manufacturing and product challenges; follow-up on actions to determine their effectiveness and suitability; and, prepare written reports on these activities in a timely fashion.
  • Perform all work in compliance with company quality and safety procedures and standards.
  • Performs other duties as assigned.

 

Studies and Experience:

  • Bachelor’s Degree in Chemical/Bioprocess Engineering, or closely related field.
  • B.S. with 3 years of experience.  -OR-   M.S. with 1 years of experience.
  • Preferred experience in a FDA regulated industry.

 

Skills and Qualifications:

  • Strong knowledge of cGMP practices along with understanding of formulation/filtration/filling.
  • Strong project management skills.
  • Experience with data analysis and statistical software competence, such as Minitab.
  • Experience in authoring and review/approval of documentation.
  • Experience with implementing changes through change control / qualification process.
  • Exhibit instrument, process, and/or method troubleshooting skills.
  • Self-directed individual who can work with limited direction. Ability to re-prioritize workload independently to address business needs.
  • Excellent organizational, analytical, and written/oral communication skills.
  • Ability to assess safety and environmental risks to ensure tasks adhere to HSE policies
  • Demonstrated ability to work in a team environment and communicate at all levels.

 

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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