Manufacturing Process Equipment Engineer

7 days ago


Denver, North Carolina, United States Biogen Full time
Job Summary

The Manufacturing Process Equipment Engineer will be responsible for designing, specifying, installing, commissioning, and validating new process equipment. This role will also provide 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 manufacturing operations by troubleshooting process equipment system issues and identifying improvements.
  • Identify and lead process equipment related projects, including technology transfers, capital projects, and modifications.
  • Provide input & guidance to Tech Transfer and area efforts, provide technical evaluations of process equipment including validation requirements for change controls and associated action plans.
  • Author and approve Trackwise generated workflows (change controls, deviations, CAPAs) for equipment/automation related changes, impact assessments, review automation protocols, and attend related meetings.
  • Coordinate process equipment/cleaning validation protocols (development, management, tracking) including time spent on manufacturing floor.

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 Power Point and MS Project.
  • Excellent organization, time management, oral and written communication skills.
  • Ability to work on-site.
  • Ability to work rotating shifts/on-call, extended coverage support and weekends as needed.

About Biogen
We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives. At Biogen, 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. Read on to learn more about our DE&I efforts. All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.

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