Hybrid Senior Engineer I, Manufacturing Sciences

at Biogen

• Job title: Senior Engineer I, Manufacturing Sciences
• Job type: Full Time
• Experience level: Senior
• Salary: $98,000 - $127,000 per year
• Degree requirement: Bachelor's Degree
• Location requirements: Hybrid, Research Triangle Park, United States

About the role

• Senior Engineer I providing subject matter expertise in manufacturing sciences for biopharmaceuticals at Biogen. Collaborating with teams on raw materials and compliance with regulations.

Responsibilities

• Serve as a technical Subject Matter Expert (SME) for single-use consumable raw materials, supplier capabilities, control strategies, and manufacturing needs 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 (e.g., filter integrity test failures), perform root cause analyses, and evaluate potential process impacts
• Perform technical risk assessments for Vendor Change Notifications (VCNs) and New Item Requests (NIRs), including chemical compatibility, stability, thermal properties, and extractables/leachables impact
• Own and support global extractables/leachables studies, ensuring alignment with current global 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

Requirements

• 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 suitability of 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.

Benefits

• Medical, Dental, Vision, & Life insurances
• Fitness & Wellness programs including a fitness reimbursement
• Short- and Long-Term Disability insurance
• A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
• Up to 12 company paid holidays + 3 paid days off for Personal Significance
• 80 hours of sick time per calendar year
• Paid Maternity and Parental Leave benefit
• 401(k) program participation with company matched contributions
• Employee stock purchase plan
• Tuition reimbursement of up to $10,000 per calendar year
• Employee Resource Groups participation