Senior Process Engineer I, Gene Therapy

Job Description

About This Role

Biogen is accelerating gene therapies that may one day help transform the way we treat neurological diseases. The Sr Process Engineer I, 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.

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Qualifications

Education
  • Bachelor's Degree with a minimum of 6 years' gene therapy or similar experience OR MBA/MS with a minimum of 4 years in gene therapy, or similar experience in a manufacturing environment

Required Skills
  • 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

Preferred Skills
  • Writing protocols, user requirements, and system design documents experience preferable




Additional Information

Biogen’s US Alzheimer’s Franchise is looking to recruit proven and ambitious sales achievers with at least five years of experience in pharma, specialty, hospital, med device/capital equipment, and/or biotech sales.
In this field-based, specialty sales representative position you will be called upon to sell our products with key stakeholders in the Alzheimer’s Disease community: including Neurologists and allied health professionals.

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