Principal Engineer, Tech Ops

The Opportunity: The Principal Process Technology (PT) Engineer is responsible for applying fundamental engineering knowledge for the design and implementation of new process technology as part of our high priority projects. Working on Capital Projects (Tier 1,2 and 3), OPEX projects and BAU activities, the Principal PT Engineer will be part of a project organization and reporting into this project organization. Own the definition, documentation, and governance of process requirements for system design and build. Leverage inputs—including technology transfer data—to derive clear, testable requirements, and apply them to drive cross-functional assessments (e.g., risk, readiness, and compliance). CSL Behring is undergoing extensive and positive change as we expand our capability and capacity. In addition to contributing to Australia’s export economy, CSL has invested in substantial new manufacturing facilities at Broadmeadows that will provide Australia with further high skills science and manufacturing employment opportunities and strengthen capabilities to develop and commercialise future new medicines onshore in Australia.

The Role

Lead end-to-end development and maintenance of process requirements for system design/build. Translate technology transfer and other inputs into measurable, traceable requirements. Establish requirement baselines, version control, and change management. Facilitate and document risk assessments, FMEAs, and process hazard analyses using the requirements. Ensure alignment with quality, regulatory, and engineering standards. Partner with design, manufacturing, QA/RA, and operations to close gaps and resolve issues. Define acceptance criteria and verification/validation approaches for process requirements. Monitor process performance, collect feedback, and drive continuous improvement. Provide governance via reviews, audits, and training on requirements management.

To be successful

Bachelor’s degree in engineering or science (or a related field), with 5+ years’ experience in Process Engineering, preferably within pharmaceutical manufacturing or pharmaceutical operations. Strong knowledge of cGMP requirements and manufacturing operations in FDA-regulated environments, including experience with validation activities and facility regulatory submission requirements. Demonstrated technical expertise in complex pharmaceutical processes and technologies, with excellent engineering problem-solving skills and a proven ability to drive effective engineering solutions. Understanding of project management principles and a track record of leading process improvements, implementing corrective actions, and delivering positive operational outcomes. Experience working in regulated environments and collaborating cross-functionally to investigate issues, identify opportunities, and drive successful resolutions. Proven ability to lead and influence cross-functional, multicultural, and international teams, while building effective partnerships and engaging stakeholders to achieve agreed business and enterprise objectives Experience with aseptic filling operations and associated technologies, including process design, technology transfer, validation, contamination control strategies, and regulatory requirements within a GMP manufacturing environment.