Manufacturing Systems Operation and Control
Operate technical systems in the manufacturing of biopharmaceuticals
Type
Domain
Competency Area
Production
Levels
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