Responsibility
• Provide process engineering support Custom Assay manufacturing.
• Act as the point of contact for engineering in supporting internal stakeholder like manufacturing team and the Quality team.
• Incorooperate technique and procedure to improve manufacturing process performance and cycle time reduction.
• Perform data analysis, trouble-shooting laboratory instrument such as Synthesizer, Mass Spectrometer and etc.
• Perform DNA synthesis, purification, quantification, packaging and labeling per specification.
• Lead and interact with multiple teams during the transfer of NPI from RnD to manufacturing.
• Write Test plan and Test cases for testing
• Perform process and product verification, robustness and stability study
• Perform Manufacturing Process Validation and Manufacturing Equipment Hardware / Software Validation (IQ/OQ/PQ)
• Verify SOPs ,Protocol and batch records for Quality control
• Document Manufacturing Hardware and Software fault found during testing.
• Provide test report and result to Project and Management team.