On January 11, 2021, we announced our intent to separate our severe genetic disease and oncology businesses into differentiated and independent publicly traded companies. We will retain focus on severe genetic disease (SGD) and will launch our oncology business (“Oncology Newco”) as a new entity, with the completed transition expected by the end of 2021.



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.

Computer System Validation Engineer (Contract)

This role is for a 9-month contract position.


We are seeking a highly motivated computer system validation (CSV) project engineer with strong skills in CSV, IT Infrastructure, and Quality. This individual will work on CSV deliverables related to the qualification of IT infrastructure, system implementation projects, and change controls at bbb, partnering with Quality Assurance Validation, IT CSV, IT Operations, and business system owners across the organization. This position is responsible for assuring that bluebird bio’s GxP computerized systems are compliant with EU, and ICH guidelines and U.S. GxP regulations.


As a Computer System Validation Engineer bird reporting to an Associate Director, you'll help to bring more patients their bluebird days by:

  • Act as IT CSV lead for CSV projects executed cross-functional teams that include Business Owners, IT System Administrators and System Owners, and Quality Assurance on projects including on-premises IT infrastructure, cloud infrastructure, enterprise SaaS software, laboratory systems, clinical systems, quality documentation and management systems, and electronic learning management.
  • Partner with IT Operations and Cloud Infrastructure to qualify core network infrastructure, and develop and qualify services for disaster recovery, backup and restore, and server/storage delivery
  • Ensure that GxP computer systems are designed, validated, and operated in compliance with internal bluebird procedures and external regulatory requirements.
  • Proactively maintain IT compliance across bluebird bio’s GxP IT Portfolio, identifying risks and proactive initiatives, when applicable
  • Participate in the review of completed software quality audit questionnaires for software development methodology, testing standards, configuration management, patches, and security assessments.
  • Partner with IT Compliance and Quality to monitor observations and issues identified during audits. Report progress, and justify or remediate the issues identified, initiating CAPA, performing gap analysis, and implementing process improvements where required.
  • Provide technical leadership and support to the bluebird bio IT organization by; assessing and make recommendations on computer-related systems, databases and tools to be used in execution of Enterprise systems.
  • Provide technical support as the Computer Systems Compliance SME during the development of system documentation such as user requirements, procedures, training modules, etc.
  • Function as IT technical lead for evaluation of validation/qualification approach.
  • Remain current in regulatory and industry trends. Educate, instruct and/or train colleagues on the same.
  • Participate in functional risk assessment for computer systems.
  • Provide direction to contract CSV engineers and be willing to mentor and provide direction on computer system validation to members of project implementation teams, as needed.
  • Other related tasks as needed


You’re the bird we’re looking for if you:

  • Strong Validation skills with at least 5+ years of experience as a CSV lead for IT Infrastructure projects
  • Strong facilitation skills to develop consensus and clarity
  • Ability to communicate and work independently with scientific/technical personnel.
  • Must have strong organizational skills and be able to execute and potentially manage projects to completion.
  • Ability to work cross functionally with all levels of the organization.
  • Project management or ASQ, Black Belt/Green Belt certification is a plus
  • Experience with laboratory systems a plus
  • Experience with Veeva platform and applications a plus
  • Active participation/knowledge of ISPE (GAMP) and/or ASQ standards a plus
  • Strong understanding and working knowledge of FDA 21 CFR Part 11, 210, and 211, ICH Q8/9/10, and EU Annex 11
  • Proficient in MS Word, Excel, PowerPoint and other applications.
  • Strong written and verbal communication skills.
  • Bachelor’s Degree in a technical discipline (Computer Science, Engineering, Chemistry/Biology).
  • Preferred: experience with Rubrik
  • Experience with QC laboratory systems is a plus.

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.

Apply for this Job

* Required


U.S. Equal Opportunity Employment Information (Completion is voluntary)

Individuals seeking employment at bluebird bio are considered without regards to race, color, religion, national origin, age, sex, marital status, ancestry, physical or mental disability, veteran status, gender identity, or sexual orientation. You are being given the opportunity to provide the following information in order to help us comply with federal and state Equal Employment Opportunity/Affirmative Action record keeping, reporting, and other legal requirements.

Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiring process or thereafter. Any information that you do provide will be recorded and maintained in a confidential file.

Race & Ethnicity Definitions

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection. As a government contractor subject to Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.

Form CC-305

OMB Control Number 1250-0005

Expires 05/31/2023

Voluntary Self-Identification of Disability

Why are you being asked to complete this form?

We are a federal contractor or subcontractor required by law to provide equal employment opportunity to qualified people with disabilities. We are also required to measure our progress toward having at least 7% of our workforce be individuals with disabilities. To do this, we must ask applicants and employees if they have a disability or have ever had a disability. Because a person may become disabled at any time, we ask all of our employees to update their information at least every five years.

Identifying yourself as an individual with a disability is voluntary, and we hope that you will choose to do so. Your answer will be maintained confidentially and not be seen by selecting officials or anyone else involved in making personnel decisions. Completing the form will not negatively impact you in any way, regardless of whether you have self-identified in the past. For more information about this form or the equal employment obligations of federal contractors under Section 503 of the Rehabilitation Act, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp.

How do you know if you have a disability?

You are considered to have a disability if you have a physical or mental impairment or medical condition that substantially limits a major life activity, or if you have a history or record of such an impairment or medical condition.

Disabilities include, but are not limited to:

  • Autism
  • Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, or HIV/AIDS
  • Blind or low vision
  • Cancer
  • Cardiovascular or heart disease
  • Celiac disease
  • Cerebral palsy
  • Deaf or hard of hearing
  • Depression or anxiety
  • Diabetes
  • Epilepsy
  • Gastrointestinal disorders, for example, Crohn's Disease, or irritable bowel syndrome
  • Intellectual disability
  • Missing limbs or partially missing limbs
  • Nervous system condition for example, migraine headaches, Parkinson’s disease, or Multiple sclerosis (MS)
  • Psychiatric condition, for example, bipolar disorder, schizophrenia, PTSD, or major depression

1Section 503 of the Rehabilitation Act of 1973, as amended. For more information about this form or the equal employment obligations of Federal contractors, visit the U.S. Department of Labor's Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp.

PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.