Senior Engineer I/II, Manufacturing Sciences – Drug Product

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 - $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
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: $111,000.00 - $149,000.00)
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
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 risk-based technical assessments
Experience supporting deviations, change controls, CAPAs, CPV, and regulatory documentation
Prior experience acting as a technical lead or SME within a manufacturing support organization
Job Level: Professional
Additional Information
The base compensation range for this role is: $98,000.00-$127,250.00
Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.
Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance.
In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees’ and their families physical, financial, emotional, and social well-being; including, but not limited to:
Medical, Dental, Vision, & Life insurances
Fitness & Wellness programs including a fitness reimbursement
Short- and Long-Term Disability insurance
A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
Up to 12 company paid holidays + 3 paid days off for Personal Significance
80 hours of sick time per calendar year
Paid Maternity and Parental Leave benefit
401(k) program participation with company matched contributions
Employee stock purchase plan
Tuition reimbursement of up to $10,000 per calendar year
Employee Resource Groups participation
Why Biogen?
We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.
At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our Biogen.
All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.