Principle Pt Engineer

Csl Behring; Melbourne; In loco; AUD 120.000 - 150.000; Tempo pieno

Descrizione del lavoro

CSL Behring in Australia is seeking a Principal Process Technology Engineer to lead end-to-end development and governance of process requirements for system design and build on capital and BAU projects. The role involves translating inputs into measurable requirements, driving risk assessments, and ensuring compliance with cGMP in FDA-regulated environments.

You will collaborate with design, manufacturing, QA/RA, and operations to close gaps, lead improvements, and support the Broadmeadows

Competenze

• Bachelor’s degree in engineering or science; 5+ years in Process Engineering.
• Strong knowledge of cGMP and FDA-regulated manufacturing environments.
• Technical expertise in complex pharmaceutical processes and technologies.
• Experience leading process improvements and corrective actions.
• Ability to lead cross-functional, multicultural teams and drive outcomes.
• Experience with regulatory submissions and validated systems.

Mansioni

• Lead end-to-end development and maintenance of process requirements for system design/build.
• Translate technology transfer and inputs into measurable, traceable requirements.
• Establish requirement baselines, version control, and change management.
• Facilitate risk assessments, FMEAs, and process hazard analyses using 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.

Conoscenze

Process Engineering

cGMP Knowledge

Regulatory Submissions

Cross-functional Collaboration

Problem Solving

Project Leadership

Formazione

Bachelor’s degree in engineering or science

Descrizione del lavoro

The Company

CSL Limited is a company that fosters a work culture emphasising Superior Performance, Innovation, Integrity, Collaboration and Customer Focus with a commitment to support, train and grow its people. As a genuine leader in the biopharmaceutical industry, CSL is a multinational ASX Listed Company that is actively growing its Australian based manufacturing operations to support global growth. CSL develops, manufactures and markets products to treat and prevent serious human medical conditions and is globally one of the largest manufacturers of plasma-derived therapies.

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