Senior Mfg Sciences Engineer, Single-Use Materials SME

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

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

Life Insurance

Wellness Program

Disability Insurance

Paid vacation

Holiday time off

Equity incentive

Cash bonus

Job summary

Biogen seeks a Senior Engineer I, Manufacturing Sciences to provide SME expertise across end-to-end single-use consumable raw materials from Drug Substance to Drug Product fill. You will collaborate with suppliers, sites, and regulatory teams to ensure materials are fit for use and compliant with evolving regulations.

The hybrid role includes on-site presence during inspections and vendor audits, with responsibilities spanning deviations, CAPAs, technical risk assessments, and regulatory filings

Qualifications

• Bachelor's degree in relevant scientific or technical field.
• 4+ years of directly relevant industry experience.
• Strong analytical skills to evaluate plastics and single-use technologies.
• Knowledge of polymers, chemistry, and single-use systems for biopharma manufacturing.
• Experience supporting deviations, change controls, CAPAs, and regulatory docs.
• Root cause analysis and risk-based assessments experience.
• Willingness to work on-site during training/critical projects/audits.

Responsibilities

• Serve as SME for single-use raw materials and supplier capabilities across the global network.
• Support development and implementation of raw material control strategies.
• Lead continuous improvement initiatives for raw materials and supplier audits.
• Conduct investigations with laboratory experiments and supplier data.
• Troubleshoot single-use material failures and assess process impact.
• Perform risk assessments for VCNs and NIRs including E/L impact.
• Own and support global extractables/leachables studies and regulatory alignment.
• Participate in industry forums and external collaborations.
• Support inspections, vendor audits, and regulatory filings.

Skills

Analytical skills

Problem solving

Regulatory documentation familiarity

Extractables & Leachables knowledge

Single-use systems knowledge

Polymeric materials knowledge

Cross-functional collaboration

On-site readiness

Education

Bachelor's degree in a relevant scientific or technical field

Tools

None

Job description

Biogen seeks a Senior Engineer I, Manufacturing Sciences to provide SME expertise across end-to-end single-use consumable raw materials from Drug Substance to Drug Product fill. You will collaborate with suppliers, sites, and regulatory teams to ensure materials are fit for use and compliant with evolving regulations.

The hybrid role includes on-site presence during inspections and vendor audits, with responsibilities spanning deviations, CAPAs, technical risk assessments, and regulatory filings