Principle PT Engineer

CSL; Broadmeadows; On-site; AUD 140,000 - 190,000; Full time

Job summary

CSL Behring is seeking a Principal PT Engineer to own the definition and governance of process requirements for system design and build on capital projects, OPEX, and BAU activities. You will leverage technology transfer data to drive cross-functional assessments and ensure alignment with quality and regulatory standards.

Join CSL Behring at Broadmeadows as part of a global biotherapeutics leader, contributing to new manufacturing facilities and onshore product development opportunities.

Qualifications

• Bachelor’s degree in engineering or science with 5+ years in Process Engineering.
• Strong knowledge of cGMP in FDA-regulated environments.
• Technical expertise in complex pharmaceutical processes.
• Understanding of project management principles and leading process improvements.
• Experience working in regulated environments and collaborating cross-functionally.
• Proven ability to lead cross-functional, multicultural, and international teams.

Responsibilities

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

Skills

Process Engineering

cGMP knowledge

Project management

Cross-functional leadership

Regulatory submission

Education

Bachelor's degree in engineering

Job description

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

About CSL Behring

CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.

CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.

To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.

Our Benefits

For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.

You Belong at CSL

At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.

To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging

Equal Opportunity Employer

CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.