Engineer III, Manufacturing Sciences - Purification
About The Position
About this role An Engineer III at Biogen provides technical and process expertise to support technology transfers and ongoing clinical and commercial manufacturing operations. This role partners closely with Manufacturing, Quality, and other technical teams to ensure processes are successfully implemented, monitored, and continuously improved. You will analyze complex data, identify trends, and design laboratory studies that support process understanding and problem-solving. The position also plays a hands-on role in observing critical manufacturing operations and supporting investigations and validation activities. This is an on-campus role based at the RTP manufacturing site. What you’ll do Serve as the downstream/purification technical lead for manufacturing issues during clinical, PPQ, and commercial processing, including impact assessments, investigations, and CAPA activities Plan, execute, analyze, and communicate purification laboratory studies supporting tech transfers, process validation, investigations, and new capabilities Perform data trending and statistical analysis for ongoing manufacturing campaigns using tools such as Tableau, Power BI, Statistica, or SIMCA Observe and support critical downstream/purification manufacturing operations during tech transfers, PPQs, and investigations Author and review technical protocols, reports, impact assessments, and GMP documentation Drive continuous improvement initiatives and technical enhancement projects Lead or support cross-functional sub-teams, escalating risks and roadblocks as needed Who you are You are a self-driven engineer with strong technical judgment who is comfortable working across manufacturing, laboratory, and quality environments. You enjoy solving complex problems, using data to inform decisions, and collaborating with cross-functional teams.
Requirements
- Bachelor’s degree in relevant scientific or technical fields from an accredited college or university
- At minimum 2 years of directly relevant industry or industry-adjacent experience
- Industry or academic experience in protein purification: chromatography, filtration, and/or centrifugation
- Demonstrated self-motivation and ability to work independently
- Ability to analyze complex data and identify process improvement opportunities
Nice To Haves
- Experience designing, executing, and interpreting laboratory studies
- Managing and influencing primary stakeholders
- Experience supporting regulatory inspections
- Experience working in a cGMP or regulated manufacturing environment
Responsibilities
- Serve as the downstream/purification technical lead for manufacturing issues during clinical, PPQ, and commercial processing, including impact assessments, investigations, and CAPA activities
- Plan, execute, analyze, and communicate purification laboratory studies supporting tech transfers, process validation, investigations, and new capabilities
- Perform data trending and statistical analysis for ongoing manufacturing campaigns using tools such as Tableau, Power BI, Statistica, or SIMCA
- Observe and support critical downstream/purification manufacturing operations during tech transfers, PPQs, and investigations
- Author and review technical protocols, reports, impact assessments, and GMP documentation
- Drive continuous improvement initiatives and technical enhancement projects
- Lead or support cross-functional sub-teams, escalating risks and roadblocks as needed
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
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
1,001-5,000 employees
