Senior Process Engineer (Pharmaceutical Manufacturing)

Location: Melbourne, Australia

Company

hirify.global provides consulting and technical support for pharmaceutical process development, manufacturing, validation, and compliance projects.

What you will do

• Lead the development and implementation of process technologies across capital projects, operational improvements, and manufacturing support activities.
• Define and maintain measurable process design requirements aligned with project objectives and regulatory expectations.
• Review process data, technology transfer packages, and manufacturing requirements to support equipment and system design.
• Support the design, commissioning, qualification, and validation of new and modified process systems.
• Lead technical evaluations, risk assessments, FMEAs, process hazard analyses, troubleshooting, and process optimisation initiatives.
• Partner with project, operations, quality, and engineering teams to resolve technical issues and implement compliant process changes.

Requirements

• Proficiency authoring and executing DQ, FAT, SAT, IQ, OQ, PQ, and PV documentation.
• Experience developing and executing CQV protocols and maintaining CQV policies and processes.
• Experience developing SOPs, final reports, validation documentation, and quality policies.
• Understanding of and compliance with cGMP and 21 CFR Part 11 requirements.
• Exposure to digital and paper-based validation systems, including Kneat.
• Background in pre-filled syringe technology, vial filling, sterile filtration, bulk product, NPI manufacturing, or plasma manufacturing.

Culture & Benefits

• Work across pharmaceutical capital projects, manufacturing operations, quality, engineering, and validation activities.
• Contribute to continuous improvement and operational readiness in a GMP-regulated environment.
• Collaborate with cross-functional teams on process integration, compliance, and technical issue resolution.