Sterility Assurance Associate

We are seeking an Associate Sterility Assurance to join a high-performing Global Quality team. Reporting to the Sterility Assurance Lead.

You will provide technical expertise and quality oversight across sterility assurance programs, collaborating closely with Manufacturing, Quality, Engineering, Validation, and Global Sterility Assurance teams. You will support the governance, implementation, and lifecycle management of sterility assurance controls while ensuring compliance with global regulatory requirements and CSL standards.

This is a part-time role (19 hours) based at our Broadmeadows site.

Key Responsibilities

• Support and maintain site-wide sterility assurance programs and microbial contamination control strategies.
• Provide technical oversight of environmental monitoring, personnel monitoring, in-process testing, finished product testing, and microbiological methods.
• Support qualification and validation activities for facilities, utilities, equipment, processes, personnel, and microbiological methods.
• Prepare and review validation protocols, reports, SOPs, risk assessments, trend reports, and quality documentation.
• Assist with investigations related to microbial contamination events, deviations, CAPAs, and root cause analyses.
• Partner with global and local stakeholders to ensure alignment with sterility assurance standards and best practices across the manufacturing network.
• Support regulatory submissions and inspections, including interactions with health authorities and auditors.
• Deliver aseptic behavior, gowning, and contamination control training to site personnel.
• Drive continuous improvement initiatives that enhance quality, compliance, and operational efficiency.

About You

You are a quality-focused professional with strong technical expertise and a collaborative mindset, who thrives in a regulated manufacturing environment.

To be successful, you will have:

• 3+ years’ experience in pharmaceutical or biopharmaceutical manufacturing with sterility assurance responsibilities.
• Experience working within aseptic processing and cleanroom environments.
• Knowledge of microbial monitoring, contamination control, validation, and lifecycle management.
• Understanding of cGMP requirements and regulatory expectations, including FDA, TGA, EU GMP, and PIC/S guidelines.
• Strong investigation, problem-solving, and risk assessment capabilities.
• Excellent communication and stakeholder management skills.
• Ability to influence cross-functional teams and drive quality outcomes.
• Ability to aseptically gown and enter sterile manufacturing environments.
• Excellent analytical thinking and risk assessment capabilities
• Ability to thrive in complex, cross-functional environments
• High attention to detail and strong documentation review skills
• Effective communication and stakeholder management skills

Why Apply?

• Work within a globally recognised pharmaceutical organisation
• Play a key role in ensuring product sterility and patient safety
• Exposure to cutting-edge sterile manufacturing technologies
• Opportunity to drive global standards and continuous improvement initiatives

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.