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
Junior to Mid-level Computer Systems Validation (CSV) Engineer
Builds
Validated computerized systems and compliant IT infrastructure for Cell Therapy, Biologics, and related life sciences manufacturing.
Domain
Life Sciences / Biopharmaceuticals / Regulated Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | infrastructure
Required skills
Computer System Validation (CSV), IT compliance, regulatory requirements (FDA, EMA, ICH Q7/Q8/Q9), 21 CFR Part 11, GAMP, Data Integrity, Change Management, Deviation Management, Risk Management, CAPA, audit support, project tracking, GxP documentation
Preferred skills
Cell Therapy or Biologics manufacturing experience, internal audit experience, ISO 9001 knowledge, Lean Six Sigma, OPEX principles
Technologies
Regulated IT systems, Quality Management Systems (QMS), validation tools, audit management tools
Responsibilities
Execute CSV activities for system changes and IT/Automation projects; support IT Deviation Management, Audit, Change Management, and Risk Management programs; support Digital Plant functional groups with CSV process implementation; provide IT quality support through review of investigations and change controls; enter and support deviations, root cause analysis, and CAPA within the Quality Management System; participate in regulatory and internal audits; track Service Level Agreements (SLA) for business-critical activities; develop and maintain GxP-related procedures and guidance documents.
Seniority
Junior to Mid-level, hands-on IC