Engineer III/Sr. Engineer I, Manufacturing Sciences – Drug Product

Biogen•Research Triangle Park, NC

1d•Onsite

About The Position

The Engineer III/Sr. Engineer I, Manufacturing Sciences serves as a scientific and technical resource supporting aseptic drug product manufacturing at Biogen’s RTP Pharma facility. The role supports production of sterile biopharmaceutical products through expertise in aseptic filling processes, technology transfers, process improvement, and partnership with GMP manufacturing to ensure reliable commercial operations. The position provides technical expertise in drug product manufacturing processes, designs and executes laboratory and manufacturing support studies, supports technology transfers, and collaborates with cross-functional teams. It also contributes to investigations, process validation, aseptic processing initiatives, change controls, capital projects, equipment implementation, and continuous improvement. The role analyzes manufacturing and experimental data and communicates technical conclusions and recommendations to stakeholders. The role has Engineer III and Sr. Engineer I qualification levels. Both require a relevant bachelor’s degree, GMP and aseptic manufacturing understanding, and willingness to work on-site more frequently during training, critical projects, audits, validation activities, and manufacturing support needs. Engineer III requires at least 2 years of relevant experience; Sr. Engineer I requires at least 4 years, including experience designing experiments, analyzing process data, executing laboratory studies, and/or supporting manufacturing investigations. Biogen describes itself as a mid-sized biotechnology company with a commitment to excellence, inclusion, and belonging. Its mission is to deliver life-changing medicines.

Requirements

Bachelor’s degree in a relevant scientific or technical field from an accredited college or university.
Engineer III: At least 2 years of directly relevant industry or industry-adjacent experience.
Sr. Engineer I: At least 4 years of directly relevant industry or industry-adjacent experience.
Familiarity with pharmaceutical or biopharmaceutical manufacturing, preferably in 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.
For Sr. Engineer I: Experience designing experiments, analyzing process data, executing laboratory studies, and/or supporting manufacturing investigations.

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, continued process verification (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, enhance process 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, perform root cause analyses, and implement 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 technical summary report authoring.
Analyze manufacturing data and experimental results, and communicate technical conclusions and recommendations to stakeholders.

Benefits

Short-term and long-term incentives, including cash bonus and equity incentive opportunities.
Medical, dental, vision, and life insurance.
Fitness and wellness programs, including fitness reimbursement.
Short- and long-term disability insurance.
At least 15 days of paid vacation and additional year-end shutdown time off (December 26–31).
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.
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.