Senior Engineer I/II, Manufacturing Sciences – Drug Product
About The Position
The Senior Engineer I/II, Manufacturing Sciences serves as a scientific and technical resource supporting aseptic drug product manufacturing at Biogen’s RTP Pharma facility. The role supports sterile biopharmaceutical production through expertise in aseptic filling processes, technology transfers, process improvement, and close partnership with GMP manufacturing to enable reliable commercial operations. The position provides technical support across formulation, sterile filtration, aseptic filling, visual inspection, and related drug product processes. It designs, plans, executes, and documents laboratory and manufacturing support studies to improve process robustness and understanding and to troubleshoot manufacturing issues. The engineer supports technology transfers into GMP manufacturing, process validation activities, media fills, PPQ campaigns, batch execution, and technical summary report writing. Working cross-functionally with Technical Development, Engineering, Quality, Validation, and Manufacturing Operations, the role supports commercial production, continuous improvement, manufacturing investigations, and aseptic processing initiatives. It analyzes manufacturing data and experimental results and communicates technical conclusions and recommendations to stakeholders. The role may support change controls, capital projects, equipment implementation, and new component introductions. The position requires a willingness and ability to work on-site more frequently during training, critical projects, audits, validation activities, and manufacturing support needs. The posting provides separate experience and salary criteria for the Senior Engineer I and Senior Engineer II levels.
Requirements
- Bachelor’s degree in a relevant scientific or technical field from an accredited college or university.
- For Senior Engineer I: at least 4 years of directly relevant industry or industry-adjacent experience; advanced degrees may be considered as relevant experience.
- For Senior Engineer II: at least 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 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.
Nice To Haves
- 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 risk-based technical assessments.
- Experience supporting deviations, change controls, CAPAs, CPV, and regulatory documentation.
- Prior experience acting as a technical lead or subject matter expert within a manufacturing support organization.
Responsibilities
- Provide technical expertise in aseptic drug product manufacturing, including formulation, sterile filtration, aseptic filling, visual inspection, and related processes.
- Design, plan, execute, and document laboratory and manufacturing support studies to improve process robustness and understanding and troubleshoot manufacturing issues.
- Lead or support drug product technology transfers into GMP manufacturing.
- Partner with Technical Development, Engineering, Quality, Validation, and Manufacturing Operations to support commercial production and continuous improvement.
- Serve as a technical subject matter expert for manufacturing investigations, conduct root cause analyses, and implement corrective and preventive actions.
- 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, including media fills, PPQ campaigns, batch execution, and authoring technical summary reports.
- Analyze manufacturing data and experimental results and communicate technical conclusions and recommendations to stakeholders.
Benefits
- Medical, dental, vision, and life insurance.
- Fitness and wellness programs, including fitness reimbursement.
- Short- and long-term disability insurance.
- A minimum of 15 days of paid vacation and additional end-of-year shutdown time off from December 26 through December 31.
- Up to 12 company-paid holidays and 3 paid days off for Personal Significance.
- 80 hours of sick time per calendar year.
- Paid maternity and parental leave benefit.
- 401(k) program with company-matched contributions.
- Employee stock purchase plan.
- Tuition reimbursement of up to $10,000 per calendar year.
- Employee Resource Groups participation.
- Short-term and long-term incentives, including cash bonus and equity incentive opportunities, for eligible regular employees.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
