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 required
  • Preferred experience related to data management and analysis. 
  • Preferred experience in an FDA regulated industry.