Engineer - Computer Systems Validation & IT Compliance
Core
Execute computer system validation (CSV) and IT compliance activities for regulated IT systems in a fully automated manufacturing environment.
Role type
Computer Systems Validation & IT Compliance Engineer
Builds
Validated computerized systems and compliant IT infrastructure for biologics/cell therapy manufacturing
Domain
Life Sciences / Biologics Manufacturing / Regulatory Compliance
Required skills
Computer System Validation (CSV), IT Compliance, Regulatory Requirements (FDA/EMA/ICH Q7/Q8/Q9), 21 CFR Part 11, GAMP, Data Integrity, Risk Management, Change Management, Deviation Management, Audit Support, Project Management, Technical Writing
Preferred skills
Cell Therapy experience, Biologics Manufacturing experience, ISO 9001 knowledge, Lean Six Sigma, OPEX principles
Technologies
GAMP, FDA 21 CFR Part 11, ICH Q7/Q8/Q9
Responsibilities
Execute assigned CSV and IT compliance activities, support computerized system changes and IT/Automation projects, support IT Deviation Management and Change Management programs, support Digital Plant functional groups with CSV process implementation, support Data Integrity and Quality Risk Management programs, review investigations and change controls, enter and support deviations and CAPA, participate in regulatory and internal audits, track Service Level Agreements (SLA), develop and maintain GxP-related procedures and documents, execute validation and change management for regulated IT systems, track project progress and provide updates to management, identify opportunities to improve CSV documentation and processes.
Seniority
Mid-level, hands-on IC