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Process Engineer

Fishers 85K - 100K Permanent

Essential Job Functions:

  • Monitor and analyze manufacturing data as necessary to provide support for process improvement and investigations.
  • Participate and support process FMEAs to understand process and product risks as a pre-requisite for process validation.
  • Mentor and train other team members.
  • Ensure successful manufacturing process comparability and process validation runs by assessing risk, setting preventative measures in place, investigating, and troubleshooting equipment and process issues.
  • Lead and ensure systematic DMAIC based approach utilization for process/product related investigations to identify root cause and provide impact assessment to maintain routine manufacturing operations and determine process improvements for manufacturing.
  • Participate and report to a cross-functional team to advance production activities.
  • Participate in evaluation of new technology and process automation for introduction into GMP manufacturing.
  • Write technical documentation (protocols & reports for equipment/instrument qualifications, comparability, process, and manufacturing process validation testing)
  • Execute engineering studies, recipe development, and validation test cases.
  • Work with vendors and suppliers to define requirements and understand functional specifications.
  • Understand manufacturing needs and adapt to the changing needs of the manufacturing environment.
  • Work flexible hours for the coverage of the production facility.

Special Job Requirements:

  • Knowledge of data management tools and RCM.
  • Bachelor’s degree or higher in chemical, electrical, or mechanical engineering, biochemistry, bioengineering, or related scientific field.
  • 3+ years’ experience in biopharmaceutical or other GXP regulated industry.

Additional Preferences:

  • CMO/CDMO experience
  • Technical and/or lean six sigma certifications
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