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    Associate Process Engineer - Durham, United States - BioFire Diagnostics

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    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:

    + Bachelors Degree in Chemical/Bioprocess Engineering, or closely related field.

    + Chemical, Mechanical, or Biomedical engineering preferred but not required

    + Preferred experience related to data management and analysis.

    + Preferred experience in an FDA regulated industry.


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