Computer Systems Validation Project Engineer
Bluebird Bio, Cambridge, Massachusetts, USA
integrated product platforms with broad therapeutic potential
bluebird bio is seeking a highly motivated Computer System Validation (CSV) Project Engineer with strong skills in CSV, IT, and Quality to join our growing team. This CSV Project Engineer will work on system implementation projects, change controls, and will assist in the development and execution of the CSV program at bbb with a specific focus on laboratory information systems (LIMS, ELN, CDS) and Quality Systems (QMS, Quality Documentation, Training). This role is an exciting opportunity to partner with Quality Assurance Validation, IT, and business system owners across the organization to ensure that bluebird bio’s GxP computerized systems are operating effectively, efficiently, and in compliance with EU, and ICH guidelines and U.S. GxP regulations.
- Act as IT CSV approver for project-related CSV documents on cross-functional teams that include Business Owners, IT System Administrators and System Owners, and Quality Assurance on projects including enterprise SaaS software, laboratory systems, quality documentation, quality management systems, electronic learning management, and other GxP systems in scope of bluebird’s Business and Manufacturing Systems team.
- Act as Validation Lead for laboratory information management system (LIMS), electronic laboratory notebook (ELN), and Chromatography Data System (CDS) implementation and qualification/validation.
- Participate as validation lead in laboratory data integrity assessments, as needed.
- 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.
- Be willing to mentor and provide direction on CSV to members of project implementation teams, as needed.
- Preferred: experience with Veeva QualityDocs, Veeva QMS, Acuta ARIM, LIMS, CDS, ELN.
- Experience with wide range of laboratory CSV and IT compliance (from development to GLP, GCP, GMP) a plus.
- Strong Validation skills with at least 5+ years of experience as a CSV lead
- Strong facilitation skills to develop consensus, clarity, and decision-making
- 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.
- Must have experience with LIMS, ENL, CDS, and QMS systems
- Ability to work cross functionally with all levels of the organization.
- Project management or ASQ, Black Belt/Green Belt certification is a plus
- Experience in GMP manufacturing environment 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, Power Point and other applications.
- Strong written and verbal communication skills.
- Bachelor’s Degree in a relevant technical discipline (Computer Science, Engineering, Chemistry/Biology), MBA a plus.
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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