Engineer II, Computer Systems Validation
Core
Support validation activities for automation systems, manufacturing equipment, and computerized systems to ensure compliance and operational readiness.
Role type
Computer Systems Validation (CSV) Engineer
Builds
Qualified commercial manufacturing systems and automation/control systems
Domain
Pharmaceutical manufacturing / GMP-regulated environments
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cGMP compliance, validation protocols (IQ/OQ/PQ), risk assessment, gap analysis, technical writing, change management, PLC/SCADA/DCS familiarity
Preferred skills
automation validation experience, change management processes, quality systems lifecycle documentation
Technologies
PLC, SCADA, DCS, DeltaV, Allen-Bradley, Microsoft Office
Responsibilities
Evaluate changes to manufacturing systems and equipment, author and execute validation documentation, perform risk assessments and gap analyses, collaborate with engineering teams to qualify system changes, ensure compliance with FDA/cGMP standards, support continuous improvement initiatives
Seniority
Junior to Mid-level, hands-on IC