Manufacturing Engineering Specialist

4 weeks ago


Denver, North Carolina, United States Biogen Full time

Job Summary

The Manufacturing Sr Engineer I is responsible for designing, specifying, installing, and validating new process equipment. This role provides engineering technical support and troubleshooting for assigned process equipment and a GMP biological manufacturing area such as Cell Culture, Harvest, or Purification.

Key Responsibilities

  • Support technology transfer of new processes into the facility
  • Provide project engineering support for new process equipment installations and modifications to existing process equipment
  • Manage medium to large engineering projects with little direction
  • Work with and provide direction to contractors
  • Participate in and lead multi-function teams to implement change and improvements on existing processes

Requirements

  • Bachelor's degree in engineering or other highly technical discipline
  • Minimum of 4 years of experience in process equipment engineering, preferably in a biologics drug substance environment
  • Experience with bioreactor, centrifugation, chromatography, and/or viral/ultra-filtration unit operations preferred
  • Practical knowledge and application of GMP regulations and guidelines (ISPE, USP, PIC/S, Annex, ICH, etc.)
  • Competency in DeltaV, MS Word, MS Excel, MS PowerPoint, and MS Project

About Biogen

Biogen is a mid-sized biotechnology company that provides the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact.

We are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve.

We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired.



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