Engineer II, Manufacturing (Rotation)
Biogen
13 hours ago
On-site
Triangle, NC
Operations
About This Role
This role provides hands-on engineering support for manufacturing and facilities operations within a rotating engineering environment. The Engineer II supports drug substance manufacturing equipment across upstream, downstream, and facilities engineering functions in a regulated GMP environment, including troubleshooting, equipment lifecycle management, validation, capital projects, and technology transfers.
What You’ll Do
- Provide technical engineering support and troubleshooting for manufacturing and facility equipment systems
- Support equipment-related projects including technology transfers, capital projects, and continuous improvement
- Develop and execute equipment commissioning, qualification, and validation protocols
- Participate in factory acceptance testing (FAT), equipment installation, startup, and commissioning
- Support investigations, change controls, deviations, CAPAs, and compliance documentation
- Collaborate with cross-functional teams, contractors, and vendors to deliver milestones
- Maintain required training, documentation, and progress tracking aligned with quality standards
Who you are
Early-career engineer interested in manufacturing and facilities engineering within a regulated environment; collaborative and detail-oriented.
Required Skills
- Bachelor’s degree in Chemical, Mechanical, Electrical Engineering, or related
- 0–2 years of engineering experience
- Basic understanding of GMP and regulated manufacturing
- Strong analytical, troubleshooting, and problem-solving skills
- Effective written and verbal communication
- Ability to work flexible hours or extended shifts
Preferred Skills
- Experience in pharmaceutical/biotechnology manufacturing
- Exposure to equipment validation, commissioning, or qualification
Benefits (as stated)
- Medical, Dental, Vision, & Life insurances; fitness & wellness with reimbursement; short- and long-term disability; paid vacation (15 days) and end-of-year shutdown (Dec 26–Dec 31); paid holidays and personal days; 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
This role provides hands-on engineering support for manufacturing and facilities operations within a rotating engineering environment. The Engineer II supports drug substance manufacturing equipment across upstream, downstream, and facilities engineering functions in a regulated GMP environment, including troubleshooting, equipment lifecycle management, validation, capital projects, and technology transfers.
What You’ll Do
- Provide technical engineering support and troubleshooting for manufacturing and facility equipment systems
- Support equipment-related projects including technology transfers, capital projects, and continuous improvement
- Develop and execute equipment commissioning, qualification, and validation protocols
- Participate in factory acceptance testing (FAT), equipment installation, startup, and commissioning
- Support investigations, change controls, deviations, CAPAs, and compliance documentation
- Collaborate with cross-functional teams, contractors, and vendors to deliver milestones
- Maintain required training, documentation, and progress tracking aligned with quality standards
Who you are
Early-career engineer interested in manufacturing and facilities engineering within a regulated environment; collaborative and detail-oriented.
Required Skills
- Bachelor’s degree in Chemical, Mechanical, Electrical Engineering, or related
- 0–2 years of engineering experience
- Basic understanding of GMP and regulated manufacturing
- Strong analytical, troubleshooting, and problem-solving skills
- Effective written and verbal communication
- Ability to work flexible hours or extended shifts
Preferred Skills
- Experience in pharmaceutical/biotechnology manufacturing
- Exposure to equipment validation, commissioning, or qualification
Benefits (as stated)
- Medical, Dental, Vision, & Life insurances; fitness & wellness with reimbursement; short- and long-term disability; paid vacation (15 days) and end-of-year shutdown (Dec 26–Dec 31); paid holidays and personal days; 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