CQV/Fill Finish Engineer - Melbourne
Core
Support CQV activities and fill finish processes in a GMP manufacturing environment, including commissioning, qualification, validation, and system integration.
Role type
CQV/Fill Finish Engineer
Builds
Pharmaceutical manufacturing facilities, utilities, equipment, and filling lines
Domain
Life Sciences / Pharmaceutical Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
CQV process expertise, fill finish process expertise, GMP compliance, data integrity principles, validation lifecycle knowledge, technical writing, project management, risk analysis, FAT/SAT/IQ/OQ/PQ execution, system integration, MES recipe management
Preferred skills
Experience with isolators, depyrogenation tunnels, sterile filtration systems, aseptic processing equipment
Technologies
MES, vial filling equipment, isolators, depyrogenation tunnels, sterile filtration systems
Responsibilities
Commission, qualify, and validate facilities, utilities, and equipment; author and review controlled documents for CQV projects; review and qualify equipment for validation activities; write and review GMP and GDP documents; initiate and coordinate risk analyses and design reviews; execute FAT/SAT, IQ, OQ, and PQ; ensure system integration with filling lines; support MES recipe startup and debugging; manage project timelines and status reporting
Seniority
Mid-level, hands-on IC
