Senior Engineer, Manufacturing Sciences — Single-Use SME

Biogen, Inc.; North Carolina; Hybrid; USD 98,000 - 127,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

Life Insurance

Fitness & Wellness program

Disability Insurance

Paid Vacation (15 days)

Job summary

Biogen, Inc. in North Carolina is seeking a Senior Engineer I, Manufacturing Sciences to provide SME-level expertise across end-to-end single-use materials from Drug Substance to Drug Product fill.

The role partners with suppliers, sites, and regulatory teams to ensure materials are compliant and capable of supporting current and future manufacturing needs. You will lead investigations, risk assessments for VCNs and NIRs, support E/L studies, and contribute to inspections and vendor audits.

Qualifications

• 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.
• Proven scientific and analytical skills to evaluate plastics and single-use technologies across multiple manufacturing modalities.
• Knowledge of polymeric materials, chemistry, and single-use systems for biopharmaceutical manufacturing.
• Experience supporting deviations, change controls, CAPAs, and regulatory documentation.
• Previous experience performing root cause analysis and risk-based technical assessments.
• Willingness and ability to work on-site more frequently during training periods, critical projects, audits, etc.

Responsibilities

• Serve as SME for single-use consumable raw materials across the global manufacturing network.
• Support development and implementation of raw material control strategies and monitoring technologies to enable incoming material release.
• Lead continuous improvement initiatives related to raw materials, including technical support for new item requests and supplier audits.
• Conduct investigations by performing laboratory experiments, gathering supplier data, developing historical trends, and assessing lot usage.
• Troubleshoot single-use material failures, perform root cause analyses, and evaluate potential process impacts.
• Perform technical risk assessments for Vendor Change Notifications (VCNs) and New Item Requests (NIRs).
• Own and support global extractables/leachables studies, ensuring alignment with regulatory guidance.
• Participate in industry forums and external E/L collaborations to advance best practices.
• Support internal and agency inspections, vendor audits, and regulatory filings related to raw materials and single-use technologies.

Skills

SME for single-use materials

Raw material control strategies

Regulatory documentation

Deviations and CAPAs

Root cause analysis

Vendor audits

Risk assessments

Cross-functional collaboration

Education

Bachelor’s degree in relevant scientific or technical fields

Bachelor’s degree in engineering, chemistry, materials science

Job description

Biogen, Inc. in North Carolina is seeking a Senior Engineer I, Manufacturing Sciences to provide SME-level expertise across end-to-end single-use materials from Drug Substance to Drug Product fill.

The role partners with suppliers, sites, and regulatory teams to ensure materials are compliant and capable of supporting current and future manufacturing needs. You will lead investigations, risk assessments for VCNs and NIRs, support E/L studies, and contribute to inspections and vendor audits.