Job Responsibilities :

• Operational Qualification Assessments (Weight: 20%)
• Develop and prepare operational qualification assessments to ensure validated critical operating parameters are maintained within qualified parameters.
• Validation Protocol Development and Execution (Weight: 20%)
• Generate and execute validation protocols including:
• Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Test Method Validation (TMV), Test Qualification Formulation (TQF)
• Process Characterization and Process Validation aligned with equipment capabilities.
• Process Equipment Qualification Studies (Weight: 15%)
• Conduct installation, operational, and performance qualification studies to verify the functionality of process equipment.
• Support for New Product Introduction (NPI) and Process Transfers (Weight: 5%)
• Assist in new product introductions and process transfer activities while adhering to regulatory requirements in a manufacturing environment.
• Perform other duties as assigned to support team goals and objectives.
• Education: Bachelor’s degree in Engineering or a related technical discipline.
• Experience: Experience in equipment qualification, process validation, and regulated manufacturing environments.
• Strong knowledge of validation protocols and industry standards.