MSAT Process Engineer, Upstream/Downstream

Durham, NC, United States
Sep 12, 2018
Required Education
Masters Degree/MBA
Position Type
Full time
bluebird bio at Research Triangle

Join bluebird bio's enthusiastic and collaborative team by contributing to the overall success of our novel gene and cell therapy approach in our new vector manufacturing facility in North Carolina's Research Triangle. As a process engineer, you will have responsibilities for critical aspects of the new facility startup. The focus of this position is to provide Upstream or Downstream process support and expertise for process transfer and GMP manufacturing operations through validation for our gene therapy products.

About The Role

  • Participates in cross functional teams for tech transfer and manufacturing support. May lead sub-teams and work as a point of contact for programs.
  • Serve as the Upstream or Downstream technical expert for the vector manufacturing process.
  • Provide technical support of GMP manufacturing runs and perform hands-on experiments in the laboratory as needed.
  • Provide hands-on support of process engineering or training runs.
  • Support Master Batch Record drafting with a strong understanding of equipment, critical process parameters, in-process testing, etc.
  • Define, measure, analyze, and propose improvements to the current process and systems.
  • Author and execute engineering studies, technical reports, change controls, and validation protocols (process, cleaning and equipment).
  • Work closely with Manufacturing, Quality Assurance, and other functions to successfully resolve deviations, investigations, change controls, CAPAs, etc.
  • Use FMEA or similar risk based approaches to troubleshoot processing issues.
  • Manage timelines and deliverables for technology transfer from Process Development and internal validation campaigns.
  • Ensure potential safety hazards are identified/shared and effective actions are rapidly implemented.
  • Embed the highest standards of compliance with our quality systems into the site's day-to-day activities.
  • Must have proficient computer skills and be experienced using MS office software (Word, Excel and PowerPoint) and MS project.
  • Must be willing to have a flexible schedule to support 24x7 manufacturing activities. Travel is expected to be approximately 10%.

About You

  • BS/MS in Engineering or a related field with 7-10+ years of experience in manufacturing sciences, manufacturing, or related areas (or a combination of education and experience).
  • Tech transfer or process validation experience is required, both are preferred. Thorough knowledge of engineering, chemistry, statistics, equipment design, process control, and process scale-up is desired.
  • Familiar with FDA and EU regulations and GMP standards. Experience with agency filings and inspections is a plus.
  • Prior cGMP cell or gene therapy manufacturing experience is highly desired.
  • Ability to work in a matrixed-team environment, meet deadlines, and self-prioritize and balance work from multiple individuals and multiple projects.
  • Exceptional verbal and technical writing skills; ability to provide focus and clarity; able to handle confidential information and material appropriately.
  • Independently motivated, detail oriented and good problem-solving ability.
  • Excellent organizational skills sufficient to multi-task in an extremely fast-paced environment with changing priorities.
  • Willingness to take on other tasks as needed to support facility start up.

Be ready to embrace the principles of the bluebird bio culture: b colorful, b cooperative, and b yourself.