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 the globe with a strong sense of our values and our purpose. Our innovation and sustainability are rooted in the diversity of our teams 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
Join bluebird bio’s enthusiastic and collaborative team by contributing to the overall success of our novel gene therapy approach. We seek an experienced Validation Engineer to support the implementation and execution of bluebird’s validation program for our internal vector manufacturing facility. This includes initial validation and qualification of equipment, utilities, facilities and CSV along with implementation of the CPV program. The candidate will assess validation packages, perform gap analysis to User Requirements and develop plans and protocols that comply with company policies and procedures. In addition, the individual will collaborate with Quality Assurance, IT, Manufacturing, and other cross-functional teams as required.
HOW YOU’LL FLY
- Write, execute, summarize and lead validation activities for: Analytical instruments, Computer Systems (applicable to complex instruments and manufacturing equipment), Equipment, Utilities, and Facilities
- Development of Validation Plans and Validation Plan Summary Reports
- Develop and provide guidance on internal validation documents including
- Develop and assess CAPAs, Change Controls, Deviations, Investigations and Risk Management as they pertain to validation
- Provide technical input to strategy/philosophy for validation activities
- Represent validation during tech transfer activities
- Front facing during agency inspections representing the validation function
- Lead and manage complex validation and technical projects
- Author and review sections of regulatory filings and annual product quality reviews
WHAT YOU’LL BRING
- Minimum of Bachelor’s degree in science, engineering or related discipline
- 4+ years of experience in the execution of validation studies in a regulated manufacturing environment
- Thorough knowledge and understanding of FDA and international health authority expectations
- Ability to effectively participate in a dynamic work environment consisting of clinical and commercial manufacturing
- Experience in authoring and review/approval of SOPs
- Superb organizational and communication skills and “do-what-it-takes” attitude
- A passion for addressing the critical unmet medical needs of patients
- Self-directed individual who is able to work with limited direction in a fast-paced, goal-oriented environment
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.