Knowledge of: purpose and basic principles of filling and sealing, including properties of packaging materials used, the principles of heat sterilisation and its effect on microbiological characteristics of the product and packaging materials, and the filling process (methods may require exclusion of air using inert gas, such as nitrogen and filling under vacuum) aseptic container preparation, handling and loading basic operating principles of aseptic filling and sealing equipment, such as main equipment components, status and purpose of guards, equipment operating capacities and applications, the purpose and location of sensors and related feedback instrumentation, and services required for operation of filling equipment used in the workplace quality characteristics and legal requirements to be achieved by the filling and sealing process, such as quality requirements of packaging components/consumables, sterilisation requirements and procedures, filling (fill levels and weights), requirements of seal formation and integrity, and where relevant, understanding integrity testing procedures the flow of processes supplying the filling and sealing process and the effect of outputs on downstream processes operating requirements and parameters and corrective action required where operation is outside specified operating parameters typical equipment faults and related causes, including signs and symptoms of faulty equipment and early warning signs of potential problems methods used to monitor the process, such as inspecting, measuring and testing as required by the process inspection or test points (control points) in the process and the related procedures and recording requirements Good Manufacturing Practice (GMP) requirements associated with the liquid manufacturing process and related control measures common causes of variation and corrective action required, including the effect of variation in both product and packaging components/consumables on filling and sealing performance, e.g. it may include an understanding of the effect of temperature variation on the filling process product/packaging changeover procedures occupational health and safety (OHS) hazards and controls, including the limitations of protective clothing and equipment relevant to the work process end-of-batch procedures, including procedures for calculating yield, materials reconciliation and action required if yield/reconciliation is not within prescribed limits, and product labelling responsibilities and procedures requirements of different shutdowns as appropriate to the process and workplace production requirements, including emergency and routine shutdowns and procedures to follow in the event of a power outage line clearance, cleaning and sanitation procedures isolation, lock out and tag out procedures and responsibilities procedures and responsibility for reporting production and performance information environmental issues and controls relevant to the filling and sealing process, including waste/rework collection and handling procedures related to the process basic operating principles of process control, where relevant, including the relationship between control panels and systems and the physical equipment sampling and testing procedures where relevant routine maintenance procedures where relevant |