Sr. Engineer/Scientist III, Manufacturing Sciences
Research Triangle Park
Tuesday, 28 April 2026
About the Role. As a member of Manufacturing Sciences, the Sr. Engineer III will provide technical expertise to the clinical and commercial manufacturing campaigns run at the Parenteral Facility Drug Product site. The focus of this position will be as a key leader for investigations and project implementation for Manufacturing Sciences using their technical expertise on fill/finish, visual inspection, and packaging. The Sr. Engineer III, Manufacturing Sciences will provide technical expertise to the clinical, PPQ, and commercial manufacturing campaigns run at the site. As appropriate, responsibilities include:Knowledge of parenteral filling (vials, cartridges, syringes) operations, lyophilization, and visual inspection activities. Lead Process & Technology Transfer teams, technical improvement projects, and technical process investigations as needed. Provide technical and operational guidance to Manufacturing during GMP campaigns. Lead technical investigations towards process impact assessments and ensure timely completion and communication. Author Manufacturing and Process Performance Qualification validation protocols and technical reports. Lead technical projects towards improved facility capabilities, efficient systems, improved technical competency, or increased process/scale-up understanding. Cultivate continuous improvement environment within the process transfer teams at the RTP site and benchmark tech transfer best practices both internal and external to Biogen, as appropriate. Subject matter Expert to support inspections and audits. Lead complex process investigations while servicing as the point of contact to broader organization. Perform data analysis to support process improvements or process transfers. Manage technical projects providing value to the Pharma site. Project Management experience in order to facilitate meetings with various stakeholders and communicate to management on the status of programs. Qualifications:Bachelors degree in Engineering or relevant scientific/technical discipline with a minimum of 8 years of relevant experience is required OR - Masters degree in Engineering or relevant scientific/technical discipline with a minimum of 6 years of direct experience OR - PhD. in Engineering or relevant scientific/technical discipline with a minimum of 4 years of direct experience. Excellent communication and project management skills appropriate for leadership of tech transfer projects. Expertise in technical understanding of Parenteral Filling Operations (e.g. Filling Isolator, Lyophilizer, Visual Inspection) including transfer of such processes into full-scale drug product manufacturing facilities. Excels at working in a team environment. Comfortable analyzing scientific datasets/strong analytical skills with excellent written skills. Ability to work independently and lead a large cross-functional group. Knowledge of cGMP, FDA/ EMA regulations, Process Performance Qualification, Continued Process Verification Job Level: Management.