Operational Readiness Support

3 days ago

Melbourne, Australia CSL Full time

**The Opportunity**:
We are looking for an Operational Readiness Associate to join our team at the Turner Facility in Broadmeadows. Reporting to the Process Specialist & Manufacturing Lead, this role is pivotal in integrating a zero-alcohol protein purification process (ZAPP) into our facility, ensuring our manufacturing staff meet the ZAPP PPQ timelines and objectives. You will also implement new process steps and equipment at the Turner facility, focusing on optimizing manufacturing usability, integration, and standardization with existing systems to meet BMW manufacturing objectives.

This exciting opportunity is a 12-month fixed term contract.

**The Role**:

- Build operational readiness activities for ZAPP integration and improve manufacturing usability.
- Ensure compliance with CSL's Code of Responsible Business Practice, Global Quality Policy, and relevant regulatory standards.
- Participate in project schedules, budget, and team meetings, providing user input for process design.
- Help with factory acceptance and site acceptance testing, and plan and complete commissioning, qualification, and validation activities.
- Coordinate training materials for manufacturing launch capacity and collaborate with the Turner manufacturing team for process runs and trials.

**Your skills and experience**:

- Tertiary qualification in science/engineering or related discipline.
- 5+ years' experience in a cGMP manufacturing environment within a pharmaceutical production setting.
- Experience in a TGA/FDA compliant manufacturing facility and proficient in problem-solving and decision-making in GMP environments.
- Knowledge of safety systems, quality management systems, and validated processes.
- Strong focus on delivering to timelines with operational focus, resilient and innovative.

LI-Onsite

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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