Avantor-posted 3 months ago
Full-time • Mid Level
Devens, MA
5,001-10,000 employees
Merchant Wholesalers, Durable Goods

Avantor is looking for a Process and Validation Engineer to be responsible for multiple phases of manufacturing processes and process improvement projects. The Process Engineer implements process improvements to meet quality standards, designs and conducts feasibility studies, and solves problems. This role will be a full-time position based out of our Devens, MA office. You will have the opportunity to develop and execute validation of equipment and processes, create necessary documentation and aides in communication to personnel and serve as a resource to site associates.

  • Responsible for analyzing production and supporting other areas as needed, identifying problems, developing countermeasures and implementation.
  • Manages data through data collection, data modeling, data analysis, cost/benefit analysis, process mapping and/or problem analysis.
  • Conduct risk assessments such as PFMEA, FMEA, 5WHYs, etc.
  • Assist with the development and execution of validation protocols for new and in use equipment and processes.
  • Systematically interacts with process owners and users to obtain feedback and to verify performance.
  • Manages the optimization of resources and processes in compliance with company policies/procedures.
  • Writes SOPs and training documents to establish standard work and develops initial documents for new processes and systems.
  • Troubleshoot equipment and hardware issues, as required.
  • Performs other duties as assigned.
  • Bachelor's degree in Industrial Engineering, Chemical Engineering, Mechanical Engineering or related area.
  • 4+ years related process engineering experience desired.
  • Experience in regulated environments (FDA or ISO 9001 preferred).
  • 2+ years experience with GMP, cleanroom and/or biopharma manufacturing processes and environments desired.
  • Project management experience a plus.
  • MS Office Suite experience.
  • Advanced software application skills (IE. Access / Visio / Minitab) desired.
  • Knowledge of Lean Manufacturing practices and the Toyota Production System (TPS).
  • Knowledge of Six Sigma process improvement methods (Green Belt preferred).
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