Senior Associate Sterility Assurance
- Employer
- CSL - Australia
- Location
- Broadmeadows, AU
- Salary
- Competitive
- Start date
- 6 Sep 2022
- Closing date
- 29 Sep 2022
View more
- Discipline
- Quality
- Hours
- Full Time
- Contract Type
- Permanent
- Experience Level
- Experienced (non-manager)
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Job Details
The Opportunity
We have an exciting permanent opportunity available for an experienced Sterility Assurance professional to join the Quality Sterility Assurance team at CSL Behring, Broadmeadows (Australia). Under the guidance of Sterility Assurance Lead, you will be the Subject Matter Expert (SME) and manage the leadership, oversight and life cycle management for the contamination control governance - cleaning and disinfection, hygiene, operator training, gowning and behaviour, facility design and process design.
The Role
As the Quality Sterility Assurance SME - Sterility Assurance Concepts, you will:
Your skills and experience
To be considered for this role you have:
How to apply: Please send us your resume and covering letter (in one document), which addresses the criteria above and includes reference number R- 177634 by September 28, 2022
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!
We have an exciting permanent opportunity available for an experienced Sterility Assurance professional to join the Quality Sterility Assurance team at CSL Behring, Broadmeadows (Australia). Under the guidance of Sterility Assurance Lead, you will be the Subject Matter Expert (SME) and manage the leadership, oversight and life cycle management for the contamination control governance - cleaning and disinfection, hygiene, operator training, gowning and behaviour, facility design and process design.
The Role
As the Quality Sterility Assurance SME - Sterility Assurance Concepts, you will:
- Provide expertise to the site related to Sterility Assurance standards
- Partner with the global function leads and site leadership team, develop strategies to ensure adherence to regulatory and CSL standards related to Sterility assurance governance and guide improvements
- Provide QA oversight of quality standards and systems aligned with the Sterility Assurance function
- Partner with your peers in Global and Local Quality Sterility Assurance from the other manufacturing sites and ensure that the same principles and systems are applied across all CSL Behring manufacturing sites
- Provide input in the generation and submission of documentation (IQ/OQ/PQ documents for microbiological method validation (sterility testing, bioburden and endotoxin)
- Collaborate in designing best practice sterility assurance controls for the microbial contamination control strategy and life cycle
- Achieve the required standards and regulatory requirements for activities affecting sterile manufacturing (Fill / Finish area including filling, sterilisers, isolator technology and auxiliary equipment, personnel training and qualification, cleaning and disinfection programmes).
Your skills and experience
To be considered for this role you have:
- Degree in Microbiology/biology life sciences
- Minimum 5 years of experience in the pharmaceutical manufacturing industry, specifically biologics with direct experience in sterility assurance of aseptic processing
- Demonstrated technical knowledge in sterility assurance of aseptic cleanroom facilities, their processes and equipment, to include microbiological monitoring, design of EM programmes, trending and microbiological method validations (sterility, endotoxin and bioburden), life cycle management and GMP compliance
- Experience leading teams for microbial monitoring of aseptic cleanrooms, processes, equipment, consumables and utilities, in-process and finished product testing and personnel monitoring
- Demonstrated experience in quality assurance and regulatory compliance with TGA, FDA, EU and other regulatory agency guidelines
- Direct experience implementing a Quality System within a manufacturing and QC Microbiology/Sterility Assurance context
- Gowning qualifications to enter aseptic filing cleanrooms
How to apply: Please send us your resume and covering letter (in one document), which addresses the criteria above and includes reference number R- 177634 by September 28, 2022
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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