Senior Aseptic Process Engineer – Manufacturing Sciences

Biogen; Milwaukee (WI); On-site; USD 98,000 - 127,000; Full time

Benefits offered by this job

Medical, Dental, Vision, & Life ins.

Fitness & Wellness programs

25 days vacation + holidays

Tuition reimbursement

Job summary

Biogen is seeking a Senior Engineer I/II, Manufacturing Sciences, to ensure reliable sterile manufacturing at its RTP Pharma facility. You will lead aseptic filling, formulation, filtration, and inspections while partnering across Technical Development, Quality, and Operations to drive process improvements and effective investigations.

You will design studies, support technology transfers, and author technical reports, with on-site presence during training, audits, and validation activities.

Qualifications

• Bachelor’s degree in relevant field is required or equivalent experience.
• 4+ years of directly relevant industry experience for Sr. Engineer I.
• 6+ years for Sr. Engineer II, in sterile or aseptic manufacturing preferred.

Responsibilities

• Provide technical expertise in aseptic drug product manufacturing across formulation, sterile filtration, aseptic filling, and inspection.
• Plan and execute studies to improve process robustness and troubleshoot manufacturing issues.
• Lead or support drug product technology transfers into GMP manufacturing.
• Collaborate with Technical Development, Engineering, Quality, Validation, and Operations to support production and improvements.
• Serve as SME for investigations, perform root cause analyses, and implement CAPAs.
• Support process validation activities, including media fills and PPQ campaigns.
• Analyze data and communicate clear conclusions to stakeholders.

Skills

aseptic drug product manufacturing

formulation

sterile filtration

aseptic filling

visual inspection

process robustness

laboratory studies

root cause analysis

CAPAs

cross-functional collaboration

Education

Bachelor’s degree in relevant scientific or technical fields

Advanced degrees may be considered as relevant experience

Job description

Biogen is seeking a Senior Engineer I/II, Manufacturing Sciences, to ensure reliable sterile manufacturing at its RTP Pharma facility. You will lead aseptic filling, formulation, filtration, and inspections while partnering across Technical Development, Quality, and Operations to drive process improvements and effective investigations.

You will design studies, support technology transfers, and author technical reports, with on-site presence during training, audits, and validation activities.