Manufacturing Systems Operation and Control

Operate technical systems in the manufacturing of biopharmaceuticals



Competency Area



Implement procedures to operate, monitor and control the status of manufacturing systems

Monitor conditions of technical systems in process plants by calling up the relevant process displays

Operate controllers to control different process variables of manufacturing systems

Analyse system data to identify factors influencing manufacturing operations

Prepare the technical systems for manufacturing processes

Check the safety, quality and accurate calibration of materials, tools and equipment in manufacturing systems

Maintain manufacturing systems in their optimal conditions, highlighting deviations to relevant personnel

Rectify system faults and restore system parameters to operational steady-state conditions

Complete and update relevant documentation and records in accordance with current organisational standards and GDP

Verify systems and controller operations and calibrate systems to perform the configured functions

Outline physical and operational interconnections among different manufacturing and process control systems

Develop guidelines and instructions for system and controller operations

Configure manufacturing and control systems to capture required data

Oversee system start-up and operations, ensuring proper protocols and Current Good Manufacturing Practices (CGMPs) are followed

Check and verify that system preparations have been performed in line with quality and safety standards

Communicate the proper calibration of materials, tools and equipment

Investigate and resolve system breakdowns, deviations or suboptimal performance

Assess and communicate risks and hazards associated with manufacturing system operations

Establish guidelines for manufacturing systems operations and control, ensuring integration and optimisation of system and process control

Integrate manufacturing plant-wide systems and process control operations

Maintain oversight of manufacturing systems performance

Establish internal Standard Operating Procedures (SOPs) for system monitoring and control

Translate system data analysis and insights into reconfiguration of manufacturing systems to optimise operations

Direct the commissioning and shut- down of manufacturing and process control systems, considering optimal timings and impact on products and processes

Formulate instructions and guidelines on how system parameters and conditions can be calibrated or adjusted to optimise performance

Provide advice to resolve highly technical or complex system faults or breakdowns

Establish plant-wide processes to manage risks and hazards associated with manufacturing system and process control equipment operations