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Senior Engineer, Tech Ops

CSL Behring -
Broadmeadows VIC

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Job Details

Full-time
12 days ago

Qualifications

Engineering
Bachelor's degree
Manufacturing
FDA regulations

Full Job Description

Entity: CSL Behring

Job Category: Engineering

Job Family: Process Engineering

Job Type: Full Time

Location: Broadmeadows, Victoria, Australia

Employer Reference: R-281007

Job Description

The Opportunity:

The Senior Process Technology Engineer plays a key role in the design, implementation, and optimisation of process technologies supporting strategic capital projects, operational excellence initiatives, and business-as-usual activities. Working within a multidisciplinary project environment, this role is responsible for defining, governing, and maintaining process requirements throughout the project lifecycle, ensuring alignment with quality, regulatory, manufacturing, and engineering standards. The successful candidate will collaborate across technical and operational functions to deliver compliant, efficient, and innovative process solutions that support CSL Behring's manufacturing objectives.

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 the development, documentation, and lifecycle management of process requirements for new and existing process technologies.
Translate technology transfer data and business needs into clear, measurable, and traceable process requirements that support system design and implementation.
Establish and maintain requirement governance, including baseline management, version control, and change management processes.
Facilitate risk assessments, process hazard analyses, and FMEA activities to identify and mitigate operational and compliance risks.
Partner with Manufacturing, Engineering, Quality, Validation, Technical Transfer, Regulatory Affairs, and other stakeholders to resolve issues and ensure project success.
Define and support verification, validation, and acceptance criteria to ensure process requirements are effectively implemented and compliant.

To be successful

Bachelor’s degree in engineering, Science, or a related technical discipline.
Minimum 5 years' experience in Process Engineering within pharmaceutical, biotechnology, or other regulated manufacturing environments.
Strong knowledge of cGMP requirements, manufacturing operations, and regulatory expectations within FDA-regulated facilities.
Demonstrated experience leading process improvement initiatives, complex technical investigations, and cross-functional project activities.
Proven ability to collaborate effectively across multidisciplinary, multicultural, and international teams while delivering practical engineering solutions.

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.

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