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Principal Engineer- Raw Material Projects

Location: Saint Louis, United States
Position Type: Unfixed Term
Job Function: Engineering

 

 

Position Summary:

Provide support for Reagent Raw Material related projects within the Reagent Operations Engineering Department. This includes leading and documenting  projects from start to finish.


Main Accountabilities:

  1. Main accountabilities are to lead and manage raw material projects. 
  2. Develop and execute change controls and other compliance related documentation for raw materials including qualification protocols.
  3. Collaborate with  Reagents Operations Engineering, Manufacturing, Purchasing, and Quality to lead projects and ensure the optimum manufacturing process in terms of keeping manufacturing moving.
  4. Organize and lead meetings as required to support project timelines.
  5. Participate in the development of long-term strategies for material and process improvements.
  6. Conduct feasibility studies on raw materials.
  7. Support root cause analysis and fishbone activities related to non-conforming materials.
  8. Provide timely and accurate reporting on projects.
  9. Ensure all activities comply with Good Manufacturing Practice (GMP), ISO, and Quality System requirements.
  10. Ensure that all health, safety, and environmental requirements are fulfilled.
  11. Support any project or task that requires keeping manufacturing  running, and ensure quality product is being shipped to customers.

 

Other Accountabilities:

 

  1. Support any project or task that requires manufacturing to keep moving, supplied with raw materials,  and ensure quality product is being shipped to customers. This can include performing NC investigation writing and disposition. 

 

Studies, Experience, Skills and Qualifications:

  • Bachelor's Degree in Process, Manufacturing, Materials, Mechanical or Industrial Engineering required
  • 3+ years project management experience is required.
  • 3+ years of experience working in a Medical Device is prefered. 
  • Ability to collaborate professionally with all levels of management in a cross-functional team environment is required.
  • Knowledge of FDA/ISO regulations and process validation is preferred.
  • Strong Knowledge of Microsoft Office (Word, Excel, PowerPoint, and Outlook) is required.
  • Must have strong communication and interpersonal skills.
  • Must have strong analytical and problem-solving skills.

 

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