Manufacturing Equipment Operation and Control
Operate production equipment ensuring optimal conditions for biopharmaceuticals manufacturing production
Type
Functional
Competency Area
Production
Levels
Implement procedures to operate manufacturing equipment
Calibrate the manufacturing equipment
Operate the equipment in accordance with SOPs
Perform routine checks on the operations of equipment to verify the processes and products acceptability in accordance with SOPs and quality standards
Monitor critical parameters
Take corrective actions to adjust equipment and other affected machinery operations
Report variations, faults or hazards in equipment operations to authorised personnel
Perform cleaning and maintenance of manufacturing equipment after use
Dispose waste and rejected by-products appropriately
Update documentation at key stages following the completion of the manufacturing processes
Verify conditions and operations of equipment and implement changes to optimise their functioning from pre-commissioning to shut-down
Develop Standard Operating Procedures (SOPs) for equipment operations
Verify the conditions and operations of manufacturing equipment components
Oversee equipment preparation and start- up
Perform procedural and safety checks on manufacturing and emergency response equipment prior to starting, during normal operations, during shut- down and during upset conditions
Verify that waste and rejected by-products are disposed of appropriately
Direct changes to critical parameters to adjust or restore equipment to optimal functioning
Resolve identified defects or faults in equipment parts or operations
Identify needs for and completion of equipment maintenance works
Mitigate risks associated with identified hazards relating to manufacturing equipment operations
Establish guidelines for the commissioning, operations and integration of manufacturing equipment in the plants
Maintain oversight of manufacturing equipment conditions and performance
Evaluate viability of commissioning new manufacturing equipment
Determine suitable timings and conditions for shut-down of manufacturing equipment and units
Establish guidelines and performance indicators of optimal equipment functioning, as well as the parameters and conditions which influence them
Write programming codes for computerised or automated manufacturing equipment
Train team members on equipment parameters and conditions to be adjusted for optimisation of performance
Provide advice to resolve highly technical or complex defects, faults or breakdowns in equipment parts or overall operations
Establish processes and mechanisms to manage risks and hazards associated with manufacturing equipment operations