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Senior Process Engineer

1 month ago

Indianapolis, Indiana, United States BioSpace, Inc. Full time
Job Summary

We are seeking a highly skilled Senior Process Engineer to join our Bioprocess Development team at BioSpace, Inc. in Indianapolis, IN. As a key member of our team, you will be responsible for providing engineering support to the maintenance and operations groups to maintain production of Bulk API for development and clinical trial purposes.

The ideal candidate will have a strong background in chemical engineering, biological engineering, or a related discipline, with a minimum of 2+ years of experience in biopharmaceutical production unit operations. Proficiency in UNICORN Software and experience with large scale column chromatography are highly desirable.

Key Responsibilities:

  • Provide engineering support in the pilot plant, including troubleshooting process and equipment issues, leading process equipment change controls, and leading process and equipment deviation investigations.
  • Perform impact and risk assessments for new processes and unit operations as needed for existing equipment.
  • Ensure processing equipment remains compliant with PR&D Quality System requirements, applicable engineering standards, and cGMP requirements.
  • Provide engineering and equipment input for tech transfer of new processes from development.
  • Active process monitoring of ongoing campaigns.
  • Provide process engineering design input for chromatography columns and buffer delivery systems.
  • Provide process engineering support for the commissioning and qualification of new equipment or re-qualification activities as needed.
  • Look for and implement opportunities for process optimization and operational excellence.

Requirements:

  • BS or MS in chemical engineering, biological engineering, or a related discipline.
  • 2+ years of experience in biopharmaceutical production unit operations.
  • Proficiency in UNICORN Software.
  • Experience with large scale column chromatography.

Preferred Skills:

  • Background in GMP biopharmaceutical production environments.
  • 3+ years of experience in biopharmaceutical production unit operations supporting antibody or protein purification operations.
  • Understanding of process control systems.
  • Problem solving skills.
  • Strong oral and written communication skills for a diverse audience.

Additional Information:

Position located in Indianapolis, IN at the Lilly Technology Center North. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions.