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Manufacturing Process Engineer
2 months ago
The Manufacturing Senior Engineer I is responsible for designing, installing, and validating new process equipment, providing technical support for assigned manufacturing areas such as Cell Culture, Harvest, or Purification. They support technology transfer into the facility, manage engineering projects, develop validation protocols, and lead teams to implement improvements on existing processes.
Key Responsibilities- Support manufacturing operations by troubleshooting equipment issues and identifying improvements.
- Lead process equipment projects including technology transfers and capital projects.
- Coordinate validation protocols and oversee equipment startup efforts.
- Participate in health authority inspections regarding engineering practices.
- Bachelor's degree in engineering or related field.
- 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 operations.
- Knowledge of GMP regulations and proficiency in relevant software.
- Strong organizational, communication, and time management skills.
- Flexibility to work on-site, rotating shifts, extended coverage, and weekends.
Biogen offers a dynamic work environment where your contributions matter. Our company values diversity and strives to create a supportive, innovative, and empowering workplace. Every team member plays a crucial role in our mission to deliver transformative medicines and impact society positively.
