Project Operations Subject Matter Expert

4 weeks ago

Broadmeadows, Australia CSL Behring Full time

**The Opportunity**:
This is a 5 year fixed term contract role and will suit someone who has knowledge of cGMP and manufacturing operations in FDA/TGA regulated facility

**The Role**:

- Assess technical detail to make recommendations for facilities/equipment design and process operations
- Provide operational knowledge and support during commissioning and qualification of new equipment, automation and software for the project
- Integrate and align BACE II with the existing BACE I procedures and processes
- Provide input and oversee change controls required for the introduction of raw materials
- Prepares and reviews Operations SOPs, Risk Assessments, Batch Documents, MES input and all other documents for C/Q/V project stages for equipment, facility and manufacturing processes

**Your skills and experience**:

- Atertiary qualification in science/engineering or related discipline
- 5 years' experience in a production area in the pharmaceutical industry
- Regulatory awareness, able to contribute to Regulatory inspection
- Highly motivated and strong influencing skills
- Project experience preferable

**Applications close 5pm AEST on the 24th February 2023**

**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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