About This Role
The Engineer III/Sr. Engineer I, 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.
Engineer III - Required Skills (Salary Range: $81,000.00 - $105,000.00)
Bachelor’s degree in relevant scientific or technical fields from an accredited college or university
At minimum 2 years of directly relevant industry or industry-adjacent experience
Familiarity with pharmaceutical or biopharmaceutical manufacturing, preferably within sterile or aseptic drug product operations
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 I - Required Skills (Salary Range: $98,000.00 - $127,000.00)
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
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
Preferred skills
Demonstrated experience supporting aseptic filling, sterile filtration, formulation, or other drug product manufacturing processes
Experience with Process Validation, aseptic process simulations (media fills), and sterile manufacturing best practices
Previous experience leading complex scientific or technical projects within a GMP manufacturing environment
Experience performing root cause analysis and…