Project Engineer Melbourne
Core
Deliver capital engineering projects for facilities, utilities, and equipment from design through commissioning and validation in GMP-regulated environments.
Role type
Senior IC Project Engineer (Capital Projects & CQV)
Builds
Pharmaceutical/biotech facilities, utility systems, and production equipment
Domain
Life Sciences / Pharmaceutical Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Capital project lifecycle management, Commissioning, Qualification, and Validation (CQV), GMP/GxP compliance, Risk-based CQV approaches, FAT/SAT/IQ/OQ/PQ execution, Technical specification writing, Procurement coordination, Stakeholder management
Preferred skills
Packing line experience, Contract administration, Quality systems knowledge
Technologies
Engineering design tools, Project management software, Quality management systems
Responsibilities
Support and deliver capital engineering projects from concept through completion, Commission, qualify, and validate facilities, utilities, and equipment, Coordinate engineering design, construction, commissioning, and validation activities, Prepare technical specifications, project documentation, and procurement requirements, Assist in authoring and reviewing controlled documents for CQV projects, Support audits, inspections, and regulatory interactions
Seniority
Mid-level, hands-on IC