Senior Process Engineer Melbourne
Core
Define and manage process requirements for pharmaceutical projects, supporting system design, technology transfer, risk assessments, and compliance in a GMP-regulated environment.
Role type
Senior Process Engineer (Pharmaceutical Manufacturing)
Builds
New and modified process systems for sterile and bulk product manufacturing
Domain
Pharmaceutical manufacturing / Biotechnology
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Process design requirements authoring, DQ/FAT/SAT/IQ/OQ/PQ/PV documentation, CQV protocols and policies, cGMP compliance, CFR21 Part 11, risk-based assessments (FMEA, PHA), technology transfer support, change management systems
Preferred skills
Pre-filled syringe (PFS) technology, Vial Filling, Sterile Filtration, Bulk Product manufacturing, New Product Initiative (NPI), Plasma Manufacturing, digital validation platforms (Kneat)
Technologies
Kneat, digital validation systems
Responsibilities
Lead technical evaluations and risk-based assessments to identify process improvement opportunities and mitigate operational risks. Support the design, commissioning, qualification, and validation of new and modified process systems. Partner with cross-functional teams to resolve technical issues and drive continuous improvement initiatives. Ensure process changes are appropriately assessed, documented, and implemented through established quality and change management systems.
Seniority
Senior, hands-on IC
