Process Validation Engineer
I have a new Process Validation Engineer role in Cork with a leading Pharma company. If you have the following experience and are interested apply today by sending your CV to email@example.com
What you will do in this process validation engineer role:
- End to end support of Manufacturing process validation.
- validate the manufacturing process
- Perform statistical analysis to prove the manufacturing process capability
- Support in overall delivery of the project.
- Responsible for verifying and validation of several machines and various process involved in it.
- Responsible for IQ/OQ/PQ methodologies and report generation.
- Preparing document in business process by identifying the business requirements.
- Understanding functional specifications and system design specifications for client
- Analyse issues recurrence to identify patterns and gaps identification, drive root cause
- analysis, and translate findings into solutions to improve workflows, processes and tools
- Interaction with manufacturing and design team to identify improvement areas in
- manufacturing process
- Interaction with supply chain management team related to manufacturing activities
- Implementation and follow the operational standards, policies and procedures.
- Optimization of manufacturing processes and methodologies
- Mitigate risks reported during the project
- Documentation of process change in engineering change management system
- Exposure to ISO13485 and ISO14971 medical standards and have exposure to risk assessment
- techniques to evaluate the associated risks, to control these risks, and to monitor the
- effectiveness of the controls.
- Knowledge of any 3D CAD software.
- Strong Technical Knowledge in Manufacturing Engineering
- Knowledge in test method development validation, development and transfer.
- Knowledge in stages of qualification like design, installation, operational and performance.
- Knowledge in preparing manufacturing process control flow chart.
- Knowledge in Risk management and Change management process.
- Knowledge in creation of Pareto chart, why-why analysis, cause & effect diagram for analysis
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