Manufacturing Engineer II

2 days ago

Triangle Township, United States Biogen Full time
Job Summary

We are seeking a highly skilled Manufacturing Engineer II to join our team at Biogen. As a key member of our manufacturing operations team, you will be responsible for designing, specifying, installing, and validating new process equipment, as well as providing engineering technical support and troubleshooting for assigned process equipment.

Key Responsibilities
  • Support manufacturing operations by troubleshooting process equipment system issues and identifying improvements.
  • Identify and support process equipment-related projects, including technology transfers, capital projects, and modifications.
  • Author and approve GMP-generated workflows (change controls, deviations, CAPAs) for equipment/automation-related changes.
  • Coordinate process equipment/cleaning validation protocols (development, management, tracking) including time spent on manufacturing floor.
Requirements
  • Bachelor's degree in engineering.
  • 0-2 years of experience in manufacturing, engineering, or validation, preferably in a biologics drug substance environment.
  • Experience with bioreactor, centrifugation, chromatography, 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.
  • Excellent organization, time management, oral, and written communication skills.
  • Ability to work on-site and 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.

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