About This Role
Biogen is accelerating gene therapies that may one day help transform the way we treat neurological diseases. The Sr Process Engineer II, Gene Therapy supports capital and operational projects including design, commissioning protocol development, and overseeing FAT and SAT testing. It also supports construction and installation of process equipment required for new processing equipment installations and modifications to existing equipment. This role leads multi-function teams to implement change and improve on existing engineering design, construction, and commissioning processes. Assignments are complex in nature where an ability to recognize deviation from accepted practice is required. Judgment is also required in resolving problems & making routine recommendations.
What You'll Do
- Identify and lead equipment related projects, including technology transfers, capital projects, and modifications
- Maintain personal training, goal development / completion, compliance workflow tracking, and progress tracking
- Provide project management oversight for small to large Opex projects
- Lead startup & execute commissioning for new and modified systems
Who You Are
You are dedicated to contributing to the generation of pioneering gene therapies. You can manage small to medium engineering projects with little direction, as well as work with and provide direction to contractors.
- Bachelor's Degree with a minimum of 8 years' experience OR MBA/MS with a minimum of 6 years in pharmaceutical or biotech manufacturing environment.
- Process engineering or technical development experience in the pharmaceutical / biotech industry supporting gene therapy unit operations
- Experience with AAV gene therapy manufacturing equipment from a design/operational lens
- Experience working with single use technology
- Experienced with operation and troubleshooting of PLC (Programmable Logic Controllers) and Delta V automation
- Experience with documentation requirements for GMP manufacturing facilities including Change Control and validation systems
- Practical knowledge and application of GMP and FDA/EMA regulations, and audit support
- Excellent verbal and written communication skills, demonstrated technical proficiency and creativity, and excellent organizational and time management skills
- Competency in Delta V, PLC, MS Word, MS Excel, MS Power Point and MS Project
- Must be able to prioritize multiple commitments and technical problems
- Must have the ability to shift priorities according to changes in department / facility needs and be open to different ideas / approaches
- Must be willing to work in an open office environment
- Writing protocols, user requirements, and system design documents experience preferable
Must be willing to participate in an on-call rotation, can work rotating shifts, extended shifts and weekends as needed.
Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients' lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.