Computer Systems Validation Engineer II

Develop standard operating procedures (SOPs) 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 plans, requirements specifications, design specifications, test scripts, and summary reports.

Participate in the development of 2seventy bio’s IT data governance policies & procedures.

Proactively maintain IT compliance across 2seventy 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.

Conduct periodic review of CSV packages for configuration reconciliation, change review, and validation maintenance.

Support inspections by regulatory agencies along with internal and external audits.

Participate in internal and external audits with responsibilities to prepare validation packages and defend 2seventy bio’s computer system validation practices and system development life cycle.

Mentor and provide direction on CSV to members of project implementation teams.

Apply experience in handling quality deviations, creating and raising quality issues and preparing CAPAs.

Position reports in to Cambridge, MA office; however, telecommuting from a home office is allowed.

Requirements:

Master’s degree in Computer Science, Engineering, Chemistry, Biology, or a related field plus five (5) years of computer system validation experience in a GMP manufacturing and laboratory environment.

Experience may be gained concurrently and must include:

Five (5) years in each of the following:

• Authoring computer systems validation documentation
• Applying strong organizational skills to execute and manage projects to completion
• Applying knowledge of FDA 21 CFR Part 11, 210, and 211, ICH Q8/9/10, and EU Annex 11

Four (4) years in each of the following:

• Performing impact assessments for laboratory system implementations and changes
• Working cross functionally with all levels of an organization

Three (3) years in each of the following:

• Creation of compliance criticality assessments
• MS Word, Excel, PowerPoint, and MS Project.

Will accept a Bachelor’s degree plus seven (7) years of described experience.

Experience may be gained before, during, or after issuance of advanced degree.