Process Engineer II
Bluebird Bio, Cambridge, Massachusetts, United States
integrated product platforms with broad therapeutic potential
Process Engineer II
ABOUT THE NEST
At bluebird, only two things matter - patients and our people. When you join the nest, you're not just landing a new gig, you become a part of a flock that's soaring to new heights. We’re 1100+ doers, thinkers and collaborators across 7 countries with a strong sense of our values and our purpose. Our innovation and sustainability are rooted in the diversity of our flock and results are achieved through cooperation and the incorporation of multiple points of view. This is personal and we approach every challenge with radical care. The time is now to rise up and recode the science, the systems, and the status quo.
ABOUT THE FLOCK
The Manufacturing Sciences & Technology flock is all about providing drug product process support for technology transfer and GMP manufacturing operations for our gene therapy products.
HOW YOU’LL FLY
As a Senior Engineer bird reporting to Associate Director, MS&T, you'll help to bring more patients their bluebird days by:
- Leading cross-functional teams in tech transfers and process validations.
- Serving as technical expert for the drug product manufacturing process on internal and external teams.
- Providing technical support of GMP manufacturing runs.
- Providing person-in-plant as needed for on-site oversight and support of process engineering or training runs.
- Must have proficient computer skills and be experienced using MS office software (Word, Excel and PowerPoint) and MS project.
- Working closely with Manufacturing, Quality Assurance, and external parties to successfully resolve deviations, investigations, change controls, etc.
- Managing timelines and deliverables for technology transfer to CMOs and conduct onsite or offsite training of contract manufacturing personnel.
- Performing process analysis and trend process performance; summarize findings in reports and presentations.
- Writing technical protocols, reports, change controls, and investigations reports.
Up to 10% travel with some potential support required on weekends
WHAT YOU’LL BRING
You’re the bird we’re looking for if you have:
- B.S., M.S. or Ph.D. in a scientific or engineering discipline and 6+ years of experience for those who have B.S. or M.S. or 3+ years for those who have a Ph.D.
- Tech transfer and process validation experience is highly desirable.
- CMO experience is a plus.
- Familiar with FDA and EU regulations and GMP standards.
- Prior cGMP cell or gene therapy manufacturing experience is desired.
- Ability to work in a team environment, meet deadlines, and prioritize and balance work from multiple individuals
- Strong 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.
All our birds embrace the principles of the bluebird bio culture: b colorful, b cooperative, b yourself.
bluebird bio is deeply committed to fostering an environment where diversity and inclusion are not only valued, but prioritized. We believe a diverse and inclusive community empowers us to act courageously, care deeply, and dream boldly to impact people in big ways. Diverse viewpoints bring diverse capabilities which strengthen our focus and fuel our growth.
bluebird is proud to be an equal opportunity employer, seeking to create a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status or any other applicable legally protected characteristics.
About Bluebird Bio
About us We are leading the gene therapy revolution. Our integrated product platforms encompass gene therapy, cancer immunotherapy and gene editing – providing us with the potential to treat, and hopefully cure, a broad range of serious diseases. We have a lot of energy, and it’s not just the abundance of coffee that keeps us going. Find out what sparks our excitement and inspires us every day.
Want to learn more about Bluebird Bio? Visit Bluebird Bio's website.
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