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Principal Process Engineer

2 months ago

Indianapolis, Indiana, United States BioSpace, Inc. Full time
Job Title: Principal Process Engineer

We are seeking a highly skilled Principal Process Engineer to join our Bioprocess Development team at BioSpace, Inc. in Indianapolis, IN.

Job Summary:

The successful candidate will be responsible for providing engineering support to the maintenance and operations groups in the pilot plant, ensuring the production of Bulk API for development and clinical trial purposes.

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.
  • Provide process engineering design input for bioreactor and primary recovery systems.
  • 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 support for the commissioning and qualification of new equipment or re-qualification activities as needed.
  • Active engagement and interaction with HSE, Quality Assurance, Tech Services, Development, Operations, FUME/C&Q, Automation, Maintenance, Environmental Monitoring, and Manufacturing.
Requirements:
  • BS in chemical engineering, biological engineering, or related discipline and 7+ years relevant experience.
  • OR MS in chemical engineering, biological engineering, or related discipline and 5+ years relevant experience.
  • Experience in production unit operations supporting cell culture and/or fermentation operations.
Preferred Skills:
  • Experience in GMP biopharmaceutical production environments.
  • DeltaV and OSI-PI proficiency.
  • Experience reading Piping and Instrumentation Diagrams.
What We Offer:

We offer a competitive salary and benefits package, as well as opportunities for professional growth and development.

At BioSpace, Inc., we are committed to creating a diverse and inclusive work environment that values and respects all employees.

We are an equal opportunity employer and welcome applications from qualified candidates from all backgrounds.