Filling Coordinator

We are looking for an experienced Coordinator to join our Facility A Filling team at our Broadmeadows site at CSL Behring. The Coordinator will support in directing daily manufacturing activities with the Facility A Filling Team resources in executing the requirements of the manufacturing schedule in a safe, GMP compliant and cost-efficient manner.

This position will suit an individual who has functional knowledge of cGMP and manufacturing operations in FDA/TGA regulated facility.

Please Note: This position is within a 24/7 operational facility, and it will be 12-hour shifts that rotate as 2 morning shifts followed by 2 overnight shifts and 4 days off.

The Role

Project:

- Play a vital role in supporting the design, commissioning, and qualification of a new filling line, with a focus on aseptic techniques and MES integration
- Collaborate with the Facility A Project Team to achieve key project deliverables and provide operational input and client review of the Facility A design through to regulatory approvals
- Deliver operational procedures and SOP's (Standard Operating Procedures) for Facility A Filling operations in accordance with the project schedule
- Integrate and align Facility A with the existing CSL Behring BMW site strategies, resources and procedures
- Provide input as well as oversee change controls related to the Facility A project

Operations:

- Provide technical support to ensure a smooth transition into routine operations, focusing on meeting and delivering manufacturing targets in full. Support small to large projects as required, actively monitor critical process measurements, and oversee facility controls to maintain consistent process capability aligned with the commissioned and validated state
- Utilise in process testing data from Quality Control and the Process Automation Control system to develop statistical models of critical control points or steps and conduct trend and range reviews to confirm the expected levels of control
- Contribute to the successful delivery of the Facility A Filling plan while ensuring the plant is operated in a cost-effective, safe and GMP-compliant manner
- Foster a culture of growth and continuous improvement by coaching and developing the production team. Focus on building individual and collective skills, providing regular feedback, and empowering team members to achieve their full potential while driving operational excellence and meeting production goals
- Ensure adherence to Good Manufacturing Practices (GMP) to produce products safely and with the highest quality standards

To be successful:

- 3-5 years' experience in a production area in the pharmaceutical industry
- Regulatory awareness, capable of contributing to Regulatory inspection
- Degree in Science, Engineering, Business is preferred
- Highly motivated and strong influencing skills

Applications close 22 February 2025.

**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.

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