Computer Systems Validation (CSV) Engineer - Melbourne
Core
Ensuring computer-based systems operate as intended and meet regulatory requirements through planning, writing, implementing, and reviewing validation protocols.
Role type
Computer Systems Validation (CSV) Engineer
Builds
Validated computer-based systems compliant with regulatory standards
Domain
Life Sciences / Healthcare / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
validation protocol design, test script creation, IQ/OQ/PQ execution, regulatory compliance knowledge, audit support, validation documentation management, data analysis for validation, process improvement recommendation
Preferred skills
operating systems knowledge, MS Office proficiency
Responsibilities
Write, review, and approve validation procedures, documents, test scripts, and final reports; maintain accurate validation documentation; analyze validation data and compile reports; support internal audits and external inspections; recommend and assist in implementing process upgrades
Seniority
Mid-level, hands-on IC