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SalaryCSL Behring has an exciting opportunity for Manufacturing Assistants (multiple positions available) to join our dynamic team in our manufacturing function (Facility F) at CSL Behring. Based at Broadmeadows and reporting to the Facility F Supervisor, you will provide subject matter expertise for the Facility F process during Facility F Projects and executing daily manufacturing process. This role will be performed under the supervision of the Facility F Supervisor in a safe, GMP compliant and cost efficient manner.The activities within the role include providing subject matter expertise regarding processes, procedures and equipment for routine manufacturing and Facility F projects. The Facility F assistant is required to follow the established procedures and methods of manufacture (BMP’s) with a focus on live process and product, to ensure the weekly manufacturing schedule is met.Please note these roles will be permanent opportunities.The RoleReporting to the Facility F Supervisor, your responsibilities will include:Project
- Collaborate with the Project Team to achieve key project deliverables and provide operational input and client review of the design through to regulatory approvals
- Provide operational knowledge and support during commissioning and qualification of new equipment and software for the Project
- Ensure the process for the engineering and validation batches is delivered in accordance with the project schedule and production schedule
- Establish effective communication between the project team and the operational team
- Encourage use of risk-based continuous improvement and operational excellence methods across the project to drive improvements in compliance, throughput, efficiency and robust operations.
- Safeguard the health, safety and security of personnel during the validation of the facility.
- Ensure that all manufacturing environments operate according to the principles of cGMP as required by relevant regulatory agencies and standards
- Ensure all production activities are performed in line with manufacturing procedures and as directed by the Supervisor/Manager
- Perform manual production activities so the weekly schedule of activities is met in a cost efficient and consistent manner. Ensure that agreed and scheduled time points are met consistently and notify the Bulk Supervisor as early as possible if there is any risk of the schedule not being met
- Follow the standard work tasks and protocols for completing a range of daily, shift and weekly tasks
- Participate in continuous improvement activities with the goal of improving product quality, compliance, and cost efficiency
- Participate in GMP inspections (TGA, FDA)
- Provide timely input into investigation and closeout oF Manufacturing deviations and CAPA’s for the area.
- Support the delivery of BOM’s (Bill of Materials) to support the manufacturing schedule
- Work with the Facility F Execution System (MES/PCS/PU’s) so the weekly schedule is met
- Strong attention to detail and the ability to follow documented processes
- A team player with proven problem-solving, demonstrated initiative and good communication skills
- Excellent written and verbal communication
- Demonstrated ability to coordinate project activities and liaise across functional groups to meet project targets and objectives
- Be flexible with regards to working hours
- Consistently demonstrate CSL values and behaviours
- Able to perform both manual tasks and work with the Facility F Execution System (MES/PCS/PU’s)
