Manufacturing Sciences Engineer — E/L SME & Raw Materials

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

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

Life Insurance

401(k) matching

Bonus opportunities

Tuition reimbursement

Job summary

Biogen is seeking a Senior Engineer I, Manufacturing Sciences to provide SME expertise for end-to-end single-use consumable raw materials, spanning Drug Substance through Drug Product fill. The role supports PO&T with material changes, deviations, CAPAs, and regulatory documentation while leading extractables/leachables programs.

You will serve as SME across global manufacturing networks, develop control strategies, and drive continuous improvement in raw materials, including supplier audits and

Qualifications

• Bachelor’s degree in relevant scientific or technical fields.
• Proven analytical skills for evaluating polymers and single-use systems.
• Experience supporting deviations, CAPAs, changes, and regulatory docs.

Responsibilities

• Serve as SME for single-use materials and supplier capabilities across global networks.
• Support development and implementation of raw material control strategies and monitoring technologies.
• Lead continuous improvement initiatives related to raw materials and supplier audits.
• Conduct investigations via lab experiments, data gathering, and trend analysis.
• Troubleshoot material failures, perform root cause analyses, assess process impact.
• Perform risk assessments for vendor changes and new item requests.
• Own and support global extractables/leachables studies aligning with regulatory guidance.
• Participate in external E/L collaborations and regulatory inspections.

Skills

SME expertise

Analytical thinking

Root cause analysis

Material/process knowledge

Regulatory documentation

On-site readiness

Cross-functional collaboration

Education

Bachelor's degree in relevant scientific or technical fields

Job description

Biogen is seeking a Senior Engineer I, Manufacturing Sciences to provide SME expertise for end-to-end single-use consumable raw materials, spanning Drug Substance through Drug Product fill. The role supports PO&T with material changes, deviations, CAPAs, and regulatory documentation while leading extractables/leachables programs.

You will serve as SME across global manufacturing networks, develop control strategies, and drive continuous improvement in raw materials, including supplier audits and