Senior Sterility Assurance Associate
Your Opportunity:
We are looking for a Senior Sterility Assurance Associate to join our Sterility Assurance team at CSL Behring. You will prioritize, organize, and communicate workload and issues/resolutions through appropriate forums and representing topics on local levels.
You will work in close collaboration with the local function, most complex Value Streams, and site leadership team to develop strategies ensuring adherence to regulatory and CSL standards related to sterility assurance governance and drive improvements. You will provide oversight of quality standards and systems aligned with the Sterility Assurance standards for the dedicated Value Stream area site.
This is a permanent opportunity based at our Broadmeadows site.
Your Role:
Reporting to the Site Lead- Sterility Assurance, you will provide support with:
- Conduct environmental and personnel Monitoring in-process testing, finished product testing, and microbiological method development.
- Oversee the validation and qualification of the facility, utility, equipment, processes, personnel, and methods at the site. This includes cleaning and disinfection, hygiene, operator training, gowning, and behaviour, facility and process design.
- Ensure compliance with quality systems related to Validation, LIMS, Calibration, Document Management, Deviation Management, CAPA, Change Control, and Enterprise Learning Management.
- Oversee proposed projects and production changes improving sterility assurance and product quality.
- Provide expert input to deviation investigations in aseptic filling and lyophilization, sterile filtration media fill, environmental monitoring, aseptic training, and bioburden test failures.
Your Experience:
- Bachelor's degree in microbiology, biology, life sciences, or an equivalent field.
- 3+ years of experience in the pharmaceutical manufacturing industry with direct experience in sterility assurance of aseptic processing/ cleanroom facilities, including design validation, monitoring, and aseptic gowning qualification.
- Expertise in quality assurance, risk assessments and regulatory compliance with cGMP, FSA, EU, and other regulatory agency guidelines.
- Demonstrated experience working with external and internal stakeholders and drive positive change.
Be part of a team that is dedicated to ensuring the highest standards of sterility assurance in the pharmaceutical industry. If you are ready to take on this exciting challenge and contribute to our mission of excellence in sterility assurance, we would love to hear from you!
Apply Now and become a vital part of our Global Quality Operations team!
#LI-Hybrid
Our Benefits
We encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL.
About CSL Behring
CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring.
We want CSL to reflect the world around us
As a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.
Do work that matters at CSL Behring!
Your Opportunity:
We are looking for a Senior Sterility Assurance Associate to join our Sterility Assurance team at CSL Behring. You will prioritize, organize, and communicate workload and issues/resolutions through appropriate forums and representing topics on local levels.
You will work in close collaboration with the local function, most complex Value Streams, and site leadership team to develop strategies ensuring adherence to regulatory and CSL standards related to sterility assurance governance and drive improvements. You will provide oversight of quality standards and systems aligned with the Sterility Assurance standards for the dedicated Value Stream area site.
This is a permanent opportunity based at our Broadmeadows site.
Your Role:
Reporting to the Site Lead- Sterility Assurance, you will provide support with:
- Conduct environmental and personnel Monitoring in-process testing, finished product testing, and microbiological method development.
- Oversee the validation and qualification of the facility, utility, equipment, processes, personnel, and methods at the site. This includes cleaning and disinfection, hygiene, operator training, gowning, and behaviour, facility and process design.
- Ensure compliance with quality systems related to Validation, LIMS, Calibration, Document Management, Deviation Management, CAPA, Change Control, and Enterprise Learning Management.
- Oversee proposed projects and production changes improving sterility assurance and product quality.
- Provide expert input to deviation investigations in aseptic filling and lyophilization, sterile filtration media fill, environmental monitoring, aseptic training, and bioburden test failures.
Your Experience:
- Bachelor's degree in microbiology, biology, life sciences, or an equivalent field.
- 3+ years of experience in the pharmaceutical manufacturing industry with direct experience in sterility assurance of aseptic processing/ cleanroom facilities, including design validation, monitoring, and aseptic gowning qualification.
- Expertise in quality assurance, risk assessments and regulatory compliance with cGMP, FSA, EU, and other regulatory agency guidelines.
- Demonstrated experience working with external and internal stakeholders and drive positive change.
Be part of a team that is dedicated to ensuring the highest standards of sterility assurance in the pharmaceutical industry. If you are ready to take on this exciting challenge and contribute to our mission of excellence in sterility assurance, we would love to hear from you!
Apply Now and become a vital part of our Global Quality Operations team!
#LI-Hybrid
Our Benefits
We encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL.
About CSL Behring
CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring.
We want CSL to reflect the world around us
As a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.
Do work that matters at CSL Behring!
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