The Opportunity:

We are looking for 24/7 Flu Cell Culture (FCC) Engineers (2 positions available) to join the FCC Manufacturing team. This will be a permanent role at Tullamarine to support the Influenza Vaccine manufacturing facility and the FCC function will be front-line support of production and process-specific issues. You will provide technical support and troubleshooting expertise to manufacturing organizations to achieve supply targets, maximize capacity and maintain equipment uptime including all related to the process, equipment, and business systems across all departments within the facility.

This will be permanent opportunity working night shifts including weekends.

Reporting to the Senior Production Manager of the area, you will:

• Provide support to manufacturing as the first line of contact for technical and operational equipment/process issues. Troubleshoot, investigate and resolve a range of major/critical equipment problems in the manufacturing facility, leading the issue resolution effort and coordinating with appropriate teams. This may include performing automation interventions that range from minor to complex in difficulty.
• Author and improve manufacturing documentation (procedures, training materials, work instructions) including revising, creating, withdrawing documentation, assisting with review and approval of documentation.
• Ownership of quality records including major deviations and incidents, site-wide DCEs, process improvement CAPAs, Level 1 and 2 change controls. Support evaluation actions for related change controls and assist with investigations related to product and process including complaints, deviations, or adverse process trends within the FCC building.
• Identify process improvements and help to bring them to implementation to ensure safe and efficient operations.
• Provide support for manufacturing systems including GLIMS, SAP and other systems.
• Help coach manufacturing staff on all operations. May provide technical training to operators and supervisors.

• Minimum of 3 years of industry experience required in the pharmaceutical/biotech industry.
• Degree in engineering or science discipline
• Technical understanding of pharmaceutical manufacturing processes and knowledge of cGMP/GMP/TGA (PIC/s)/FDA/EU/OGTR/DAFF/EMA regulations
• Knowledge of Quality Management Systems
• Have an in-depth understanding of all areas and operations within FCC manufacturing, including an understanding of the relationship between the process, equipment, documentation and automation in the FCC facility.
• Gowning for clean room entry is a requirement of the position as is the wearing of mandated PPE (safety glasses, safety shoes etc.)
• All employees working in the Flu Cell Culture (FCC) Manufacturing Facility, or those with the potential to, are required to consent to undergo vaccination against any relevant influenza virus as may be reasonably required by CSL Seqirus at the earliest possible time when vaccine is available upon the commencement of employment.