Your Opportunity:
We are seeking a Senior Sterility Assurance Associate to join our Sterility Assurance team at CSL Behring.
You will collaborate closely with the local function, 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.
This is a permanent opportunity based at our Broadmeadows site.
Your Role:
* 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.
* 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 driving positive change.
About CSL Behring:
CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases.
Career Benefits:
We encourage you to make your well-being a priority. It's important and so are you.