Sr Engineer Computer Systems Validation
Core
Execute computer system validation (CSV) and IT compliance activities for regulated computerized systems in a biologics and cell therapy manufacturing environment.
Role type
Senior IC Computer Systems Validation (CSV) Engineer
Builds
Validated IT systems and compliant digital processes for Cell Therapy Facility and broader manufacturing operations
Domain
Life Sciences / Biologics Manufacturing / Regulated IT
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Computer System Validation (CSV), IT Compliance, Change Management, Deviation Management, Risk Management, Data Integrity, Regulatory Audits, GxP compliance, Project Management, Technical Writing
Preferred skills
Cell Therapy experience, Biologics Manufacturing knowledge, Lean Six Sigma, OPEX principles, Internal Auditing, Mentoring
Technologies
FDA 21 CFR Part 11, GAMP, ISO 9001, ICH Q7/Q8/Q9
Responsibilities
Execute assigned CSV and IT compliance activities for the Devens Cell Therapy Facility; Serve as CSV subject matter expert for computerized system changes; Support IT Deviation Management, Computer System Audit, Change Management, and Risk Management programs; Provide guidance to Digital Plant groups on CSV process implementation; Support Data Integrity and Quality Risk Management programs; Review and approve investigations and change controls; Enter and support deviations, root cause analysis, and CAPA within the Quality Management System; Participate in regulatory and internal audits as a Digital Plant representative; Track Service Level Agreements (SLA) for business-critical activities; Develop and maintain GxP-related procedures and documentation.
Seniority
Senior, hands-on IC