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.
Computer System Validation Engineer (Contract)
This role is for a 9-month contract position.
ABOUT THE FLOCK
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.
HOW YOU’LL FLY
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
WHAT YOU’LL BRING
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.