Job Description

The Opportunity

We are looking for an experienced Project Operations Subject Matter Expert (SME) to join our team at our Broadmeadows site at CSL Behring. Reporting to the BACE II Operational Readiness Lead, you will provide subject matter expertise to support the BACE II Operations team during the project phase for Aseptic filling, Pasteurisation and Incubation. You will actively participate in the BACE II project team collaborating with project leaders/teams to support operations requirements for design/commissioning/qualification/validation, and licensure of the facility and registration of manufacturing process for commercial operation.

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

Apply now to join a growing business in a great team environment. Please include your cover letter and application in one document.

Applications close 5pm AEST on the 29th June 2023.

About Us

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.

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.

As a global organisation with employees in 35+ countries, CSL embraces diversity, equity and inclusion. Learn more about Diversity, Equity & Inclusion at CSL.