Senior Engineer I​/II, Manufacturing Sciences – Drug Product

Location: Northern

## Senior Engineer I/II, Manufacturing Sciences – Drug Product Apply:
On Campus:
Research Triangle Park, NC:
Full time:
Posted Today:
REQ
24339
** About This Role
** The Senior Engineer I/II, Manufacturing Sciences serves as a key scientific and technical resource supporting aseptic drug product manufacturing at Biogen’s RTP Pharma facility. This role enables the successful production of sterile biopharmaceutical products by providing expertise in aseptic filling processes, supporting technology transfers, leading process improvement initiatives, and partnering closely with GMP manufacturing to ensure reliable commercial operations.
** What You’ll Do
*** Provide technical expertise in aseptic drug product manufacturing, including formulation, sterile filtration, aseptic filling, visual inspection, and associated drug product processes
* Design, plan, execute, and document laboratory and manufacturing support studies to improve process robustness, enhance process understanding, and troubleshoot manufacturing issues
* Lead or support drug product technology transfers into GMP manufacturing
* Partner cross-functionally with Technical Development, Engineering, Quality, Validation, and Manufacturing Operations to support commercial production and continuous improvement efforts
* Serve as a technical SME for manufacturing investigations, performing root cause analyses and implementing effective corrective and preventive actions (CAPAs)
* Support aseptic processing initiatives, including process monitoring, contamination control strategies, and operational excellence activities
* Represent Manufacturing Sciences in change controls, continuous improvement efforts, capital projects, equipment implementation, and new component introductions
* Support process validation activities, including media fills, PPQ campaigns, batch execution support, and authoring technical summary reports
* Analyze manufacturing data and experimental results, communicating clear technical conclusions and recommendations to stakeholders
** Who You Are
** You are a hands-on, scientifically driven problem solver with experience supporting sterile pharmaceutical manufacturing operations. You enjoy collaborating across functions, investigating complex technical challenges, and leveraging data to improve process performance, product quality, and manufacturing reliability.
** Sr. Engineer I - Required Skills** (Salary Range: $98,000.00 - $)
* Bachelor’s degree in relevant scientific or technical fields from an accredited college or university
* At minimum 4 years of directly relevant industry or industry-adjacent experience  + Advanced degrees may be considered as relevant experience
* Familiarity with pharmaceutical or biopharmaceutical manufacturing, preferably within sterile or aseptic drug product operations
* Experience designing experiments, analyzing process data, executing laboratory studies, and/or supporting manufacturing investigations
* Understanding of GMP requirements and aseptic manufacturing principles
* Willingness and ability to work on-site more frequently during training periods, critical projects, audits, validation activities, and manufacturing support needs
** Sr. Engineer II - Required Skills** (Salary Range: $ - $)
* Bachelor’s degree in relevant scientific or technical fields from an accredited college or university
* At minimum 6 years of directly relevant industry or industry-adjacent experience  + Advanced degrees may be considered as relevant experience
* Familiarity with pharmaceutical or biopharmaceutical manufacturing, preferably within sterile or aseptic drug product operations
* Experience designing experiments, analyzing process data, executing laboratory studies, and/or supporting manufacturing investigations
*…