Process Validation Engineer

Job Description

Job Overview:

• 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 engagements. 
• 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 the 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.

Educational qualification:

• Bachelor's degree in Mechanical/Production Engineering 

Added advantage - Knowledge in the below topics. 

• 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.