About the role
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 are recruiting a Project Engineer to join our team at our manufacturing facility at 189–209 Camp Road, Broadmeadows, VIC 3047.
Description of the role
The Project Engineer will provide project and design support to the Project Manager or Senior Project Manager and the team to ensure that the specified project requirements are implemented to specification, time, quality and within budget to a successful handover to the end user. You will also support end-to-end delivery of Lifecycle Management (LCM) projects, ensuring regulatory, validation and operational readiness requirements are met.
This is a Permanent full-time position.
Key Responsibilities:
- Support project activities as part of the team managed by Project Manager and/or Senior Project Manager.
- Works under limited supervision for routine situations
- Assist in the management of small to medium size projects (team typically less than 5 people; low to medium project complexity and technical complexity).
- Prepare and seek approval of Capital Expenditure Proposals, as instructed.
- Raise and administer purchase orders for supply of goods and services.
- Assist as directed in the preparation of key project management documents.
- Provide assistance as directed in maintaining the configuration management system during project activities.
- Plan and oversee execution of PPQ batches, stability studies, and cleaning validation activities, ensuring cross-functional alignment and timely issue resolution.
- Coordinate LCM changes within operating areas, planning work to minimise downtime and avoid impacts to routine manufacturing schedules.
- Prepare senior leadership updates on regulatory, validation and operational readiness status, including risk mitigation and contingency planning.
- Ensure that project tasks are managed in a way that creates a safe, healthy and secure workplace for the staff and contractors involved in implementing projects and for those using the facilities created or modified by these projects.
- Support lifecycle upgrades and process improvements that enhance product robustness, regulatory compliance, and operational efficiency, including coordinating validation strategy, PPQ readiness, and documentation updates
Qualifications and Experience required:
- Tertiary qualifications in engineering, or science.
- Strong understanding of GMP principles, qualification practices, validation lifecycle management and regulatory compliance requirements
- Proficiency in writing and executing qualification protocols (IQ/OQ/PQ), and supporting Process Performance Qualification (PPQ) activities
- Fundamental understanding of technical development concepts, tools and technologies as well as design techniques.
- Fundamental level of technical knowledge in one Engineering discipline and ability to solve problems in design, testing and deployment.
- Experience in troubleshooting, process engineering and ability to understand and implement client requirements. Experience
- An underlying Project Management experience.
- An underlying process and engineering systems/services experience gained in the GxP industry. Knowledge & Attributes
- An underlying knowledge of project management principles.
- Ability to manage multiple concurrent regulatory submission pathways and adjust project deliverables to meet varied global compliance requirement
- Strong stakeholder management skills, with proven ability to engage SMEs, global regulatory stakeholders and senior leadership
- Excellent communication skills (written and verbal).
- Intermediate skills in MS-Project, MS-Excel, MS-Word, MS-PowerPoint, MS-Visio and MS-Outlook.
- An underlying understanding and application of GxP principles.
Application Period: Applications open on 10 June and close on 10 July 2026.
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.
Aplyr's read
CSL is a leader in biotechnology, focusing on therapies for rare diseases, with a diverse team dedicated to innovation and global impact.
What's promising
- •CSL has a strong focus on rare and serious diseases, offering a unique niche in the biotech industry.
- •Recent hiring for senior roles indicates growth and investment in leadership and strategic capabilities.
- •Global presence provides employees with opportunities for international collaboration and career development.
What to watch
- •Highly specialized focus may limit opportunities for those outside the biotechnology field.
- •Complex regulatory environment can pose challenges for compliance and operational efficiency.
- •Rapid expansion may lead to integration challenges across diverse global teams.
Why CSL
- •CSL's commitment to rare disease therapies differentiates it from broader-focused biotech firms.
- •The company offers a wide array of roles, from regulatory affairs to ethics and compliance.
- •CSL's global operations provide a platform for employees to engage in diverse cultural and professional experiences.
Aplyr’s read is generated by AI from public sources. Was it useful?
About CSL
CSL is a global biotechnology company that develops and delivers innovative therapies for people with serious and rare diseases.