Engineer III, Manufacturing Sciences - Purification
Biogen
9 hours ago
On-site
Triangle, NC
Operations
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
- Self-driven engineer with strong technical judgment; comfortable working across manufacturing, laboratory, and quality environments; enjoys solving complex problems with data and collaborating cross-functionally.
Required Skills
- Bachelor’s degree in relevant scientific or technical fields
- At least 2 years of directly relevant industry or industry-adjacent experience
- Protein purification experience (chromatography, filtration, and/or centrifugation)
- Demonstrated self-motivation and ability to work independently
- Ability to analyze complex data and identify process improvement opportunities
Preferred Skills
- 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
Benefits (if offered)
- Base compensation range: $79,000.00–$103,000.00
- Medical, Dental, Vision, & Life insurances; fitness & wellness programs; disability insurance; paid vacation and holidays; sick time; paid maternity/parental leave; 401(k) with match; employee stock purchase plan; tuition reimbursement up to $10,000/year; Employee Resource Groups participation
- 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
- Self-driven engineer with strong technical judgment; comfortable working across manufacturing, laboratory, and quality environments; enjoys solving complex problems with data and collaborating cross-functionally.
Required Skills
- Bachelor’s degree in relevant scientific or technical fields
- At least 2 years of directly relevant industry or industry-adjacent experience
- Protein purification experience (chromatography, filtration, and/or centrifugation)
- Demonstrated self-motivation and ability to work independently
- Ability to analyze complex data and identify process improvement opportunities
Preferred Skills
- 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
Benefits (if offered)
- Base compensation range: $79,000.00–$103,000.00
- Medical, Dental, Vision, & Life insurances; fitness & wellness programs; disability insurance; paid vacation and holidays; sick time; paid maternity/parental leave; 401(k) with match; employee stock purchase plan; tuition reimbursement up to $10,000/year; Employee Resource Groups participation