Site Lead Sterility Assurance

2 weeks ago

Broadmeadows, Australia CSL Behring Full time

**The Opportunity**:
Join the CSL Behring team on a **full-time ongoing** basis in this important quality role. CSL Behring Broadmeadows manufactures a comprehensive portfolio of 15 plasma products for Australia from plasma collected by Lifeblood Australia. Part of the global CSL family, when you join the over 1200 employees at Broadmeadows, you join an integrated global network of research and manufacturing facilities delivering on our 100-year-old promise to save lives using the latest technology.

Reporting to the Global Director, Sterility Assurance and working **on site** at **Broadmeadows**, you will lead the lifecycle management for the contamination control governance elements including sterility assurance concepts, validation and monitoring controls. You will set objectives and provide strategic leadership relating to sterility assurance standards, culture, and continuous improvements and you will work with global colleagues to provide a holistic microbial contamination control strategy and improvement plan for the site and harmonise principles and systems.

**The Role**:
As the Site Lead Sterility Assurance, you will:

- Guide the development, implementation and maintenance of sterility assurance standards and processes with following global governance, regulatory requirements, and industry standards
- Collaborate with internal and external partners to design best practice sterility assurances controls for the microbial contamination control strategy and life cycle management
- Use your knowledge of the facility, processes and equipment to design the validation controls for the aseptic facility including the environmental monitoring program and in-process and finished product monitoring and also to design the microbial controls for the aseptic facility including the aseptic media fill simulation program, container closure integrity and validation of the HVAC and HEPA systems
- Establish quality on the floor processes for critical cleanliness and aseptic behaviour
- Use your knowledge of the facility, processes and equipment to design the validation controls for the aseptic facility including the environmental monitoring program and in-process and finished product monitoring and also to design the microbial controls for the aseptic facility including the aseptic media fill simulation program, container closure integrity and validation of the HVAC and HEPA systems
- Manage a team of sterility assurance SMEs and quality professionals to achieve the global and site goals relating to sterility assurance.

**Your skills and experience**:
To be considered for this role you have:

- A degree in microbiology or other biology life sciences
- 8+ years’ experience in the pharmaceutical manufacturing industry with experience in sterility assurance of aseptic processing
- 5+ years’ experience in the manufacturing of biologics
- Experience leading teams in aseptic cleanrooms, process, equipment, consumables and utilities, validation, and microbiological monitoring
- Experience in quality assurance and regulatory compliance with cGxP, TGA, FDA EU and other regulatory agency guidelines
- Experience leading a technical team in a regulated environment and providing technical support
- Experience presenting complex information and conceptual and analytical thinking to reconcile ambiguities and influence outcomes
- The ability to aseptically gown and enter aseptic filling cleanrooms
- Experience preparing and reviewing technical and other documents, protocols, reports and SOPs.

**How to Apply**:
**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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