Sterility Assurance Specialist

3 days ago

Melbourne, Australia CSL Full time

Your Opportunity

At CSL Seqirus, we are driven by our promise to protect public health. As one of the world’s largest influenza vaccine providers, we are committed to innovation and excellence in everything we do.

We are currently seeking a Sterility Assurance Specialist to join our team at Parkville site. As a Sterility Assurance Specialist, you will play a key role in ensuring our aseptic manufacturing environments meet the highest standards of compliance and quality. You will support contamination control strategies, environmental monitoring, and aseptic process governance across our manufacturing operations.

This is a 12-month Fixed term role and is based at our Parkville site, with the expectation to work from Tullamarine as needed to support operational requirements.

Your Responsibilities

Reporting to the Site or Regional Lead of Sterility Assurance, you will:

- Support and maintain sterility assurance systems aligned with global standards and GMP regulations.
- Lead and contribute to contamination control strategies, including aseptic process simulation, cleaning and disinfection programs, and aseptic behavior training.
- Collaborate with cross-functional teams to drive continuous improvement and ensure regulatory compliance.
- Participate in internal audits, inspections, and regulatory submissions as a Sterility Assurance SME.
- Support deviation investigations and change control processes related to aseptic manufacturing.

Your Experience
- Bachelor’s degree in Microbiology, Biochemistry, Pharmaceutical Sciences, or a related field.
- Strong background in aseptic manufacturing, sterility assurance, and quality assurance preferably in a pharmaceutical manufacturing or a cGMP-regulated environment.
- Experience in environmental monitoring, microbiology, and contamination control.
- Proven ability to work collaboratively across teams and influence key stakeholders.
- Ability to gown and work in cleanroom environments is essential.

Join Us

**Our Benefits**:
CSL Seqirus is committed to attracting and retaining world-class employees who are valued for their contributions to achieving business objectives. Learn more about some of the benefits you can participate in when you join CSL Seqirus.

**About CSL Seqirus**:
CSL Seqirus is part of CSL Limited (ASX: CSL). As one of the largest influenza vaccine providers in the world, CSL Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. In Australia, CSL Seqirus is also a leading provider of speciality pharmaceuticals and other essential vaccines. Learn more about CSL Seqirus.

**We want CSL Seqirus to reflect the world around us**:
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. Learn more Inclusion and Belonging | CSL.

**Do work that matters at CSL Seqirus**:

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