Associate Process Engineer

2 weeks ago


Durham, North Carolina, United States bioMerieux SA Career Site - MULTI-LINGUAL Full time

Description

Position Summary:

As part of the Industrialization department, the Process Engineer will develop and/or manage process improvement projects to support 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, HSE, and other functions as required, to ensure successful project achievements and 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.

Primary 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.

Education, Skills, & Experience:

Bachelor's Degree in Chemical/Bioprocess Engineering, or closely related field.Chemical, Mechanical, or Biomedical engineering preferred but not requiredPreferred experience related to data management and analysis. Preferred experience in an FDA regulated industry.
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