bluebird bio's Global Information Technology team is on a mission to deliver smart, innovative technology solutions and services to the organization and our patients. We move fast here at bluebird, working together as ONE in building a legendary gene therapy company, bringing hope to patients and their families. As a member of bluebird's IT team, you'll have the opportunity and privilege to develop technology solutions and services that will support patients, care givers and the healthcare organizations serving them. We are a passionate, hardworking and friendly flock of IT birds who are looking for individuals to step outside their comfort zone, roll up their sleeves and help us scale this organization to influence the industry of cell and gene therapy, while learning and growing along the way. We invite you to recode for life with us!
About the role:
* Develop procedures and work instructions for computer system validation (CSV) including procedures for GxP system development life cycle, creation of validation deliverables, CSV project management, and software vendor quality audit questionnaires.
* Act as IT CSV approver for project-related CSV documents on cross-functional teams that include Business Owners, IT CSV project engineers, IT System Administrators and System Owners, and Quality Assurance on projects including clinical data repositories, master data management systems, laboratory systems, and other systems supporting clinical or quality processes.
* Develop templates for CSV deliverables including validation plan, requirements specifications, design specification, test scripts, and summary reports
* Participate in the development of bluebird's IT data governance policies & procedures
* Act as business administrator for bluebird's automated system life cycle software application, including managing accounts, change/patch management, and any associated maintenance.
* 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
* Help develop and deliver training related to computer system validation and CSV testing
* Periodic Review of CSV packages for configuration reconciliation, change review, and validation maintenance
* Participate in internal and external audits with responsibilities to prepare validation packages and defend bluebird's computer system validation practices and system development life cycle
* Be willing to mentor and provide direction on CSV to members of project implementation teams, as needed.
* 3-5 years of Computer System Validation experience in a GMP/GCP environment is required
* Experience in GCP environment is a plus
* Strong facilitation skills to develop consensus and clarity, Ability to communicate and work independently with scientific/technical personnel is required
* Strong understanding and working knowledge of FDA 21 CFR Part 11, 210, and 211, ICH Q8/9/10, and EU Annex 11 is required
* Project management or ASQ, Black Belt/Green Belt certification is a plus
* Active participation/knowledge of ISPE (GAMP) and/or ASQ standards is a plus
* Proficient in MS Word, Excel, Power Point and other applications
* Strong written and verbal communication skills
* Bachelor's Degree in a technical discipline (Computer Science, Engineering, Chemistry/Biology)
About Bluebird Bio
Bluebird Bio offers products based on the transformative potential of gene therapy for patients with genetic and orphan diseases.