Senior Manufacturing Sciences Engineer - Single-Use SME

Biogen, Inc.; Northern (KY); Hybrid; USD 98,000 - 127,000; Full time

Benefits offered by this job

Medical, Dental, Vision, Life ins.

Wellness programs & fitness reimburse.

Vacation & holidays

Job summary

Biogen is seeking a Senior Engineer I in Manufacturing Sciences to provide SME-level guidance on single-use materials and extractables/leachables. You will drive material control strategies, support vendor audits, and collaborate with sites globally to ensure regulatory readiness.

The role requires 4+ years in biotech manufacturing, strong root cause analysis, and experience with CAPAs, deviations, and regulatory documentation.

Qualifications

• Bachelor’s degree in engineering or related technical field.
• 4+ years of directly relevant experience in manufacturing or biotech.
• Experience with deviations, change controls, CAPAs, and regulatory documentation.
• Hands-on experience with extractables and leachables is preferred.

Responsibilities

• Serve as SME for single-use materials and E/L programs across global manufacturing.
• Support development and implementation of raw material control strategies and monitoring.
• Lead investigations with lab experiments and supplier data to inform trends and lot usage.
• Perform risk assessments for vendor changes and new item requests.
• Own and support global extractables/leachables studies with regulatory alignment.
• Assist with inspections, vendor audits, and regulatory filings related to materials.

Skills

SME single-use materials

CAPA & deviations

Root cause analysis

E/L knowledge

Education

Bachelor’s degree in engineering or related

Job description

Biogen is seeking a Senior Engineer I in Manufacturing Sciences to provide SME-level guidance on single-use materials and extractables/leachables. You will drive material control strategies, support vendor audits, and collaborate with sites globally to ensure regulatory readiness.

The role requires 4+ years in biotech manufacturing, strong root cause analysis, and experience with CAPAs, deviations, and regulatory documentation.