Sr Engineer I, Manufacturing Sciences
Biogen
August 20, 2026
Remote friendly (Triangle, NC)
United States
Operations
What You’ll Do
- 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
Required Skills
- 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.
Preferred Skills
- Bachelor’s degree in engineering, chemistry, materials science, or a related technical field from an accredited college or university
- Hands-on experience with extractables and leachables studies and regulatory expectations
- Familiarity with single-use systems, container closure systems, and supplier change management
- Experience supporting regulatory inspections and vendor audits
- Prior experience acting as a technical lead or SME within a manufacturing or engineering organization
- Participation in industry forums, external collaborations, or technical working groups related to E/L or single-use technologies
- Previous experience partnering with external contractors and vendors
Benefits
- Medical, Dental, Vision & Life insurances
- Fitness & Wellness programs including fitness reimbursement
- Short- and Long-Term Disability insurance
- Minimum 15 days paid vacation plus end-of-year shutdown (Dec 26–Dec 31)
- Up to 12 company paid holidays + 3 paid days off for Personal Significance
- 80 hours sick time per calendar year
- Paid Maternity and Parental Leave
- 401(k) with company matched contributions
- Employee stock purchase plan
- Tuition reimbursement up to $10,000 per calendar year
- Employee Resource Groups participation
- 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
Required Skills
- 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.
Preferred Skills
- Bachelor’s degree in engineering, chemistry, materials science, or a related technical field from an accredited college or university
- Hands-on experience with extractables and leachables studies and regulatory expectations
- Familiarity with single-use systems, container closure systems, and supplier change management
- Experience supporting regulatory inspections and vendor audits
- Prior experience acting as a technical lead or SME within a manufacturing or engineering organization
- Participation in industry forums, external collaborations, or technical working groups related to E/L or single-use technologies
- Previous experience partnering with external contractors and vendors
Benefits
- Medical, Dental, Vision & Life insurances
- Fitness & Wellness programs including fitness reimbursement
- Short- and Long-Term Disability insurance
- Minimum 15 days paid vacation plus end-of-year shutdown (Dec 26–Dec 31)
- Up to 12 company paid holidays + 3 paid days off for Personal Significance
- 80 hours sick time per calendar year
- Paid Maternity and Parental Leave
- 401(k) with company matched contributions
- Employee stock purchase plan
- Tuition reimbursement up to $10,000 per calendar year
- Employee Resource Groups participation