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Acted as automation lead in technical transfer of new product introduction into thr facility.
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Recipe authoring using Emerson Syncade MES and DeltaV (DCS) for downstream purification processes such as chromatography, viral inactivation, buffer preparation, bulk drug substance filling and freezing.
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Collaboration with multiple stake holders i.e MS&T, project manager and customer to develop and review process documentation, such as standard operating procedures (SOPs), Electronic batch records (EBRs) and other operational documentation, ensuring alignment with regulatory standards and best practices.
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24/7 on call front line support, assisting with troubleshooting, decision making and deviation root cause analysis during production of multiple products simultaneously
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Development, testing and implementation of new recipes for product freezing and reprocessing in the event of FIT failures.
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Designing and delivering technical training sessions for manufacturing operations, equipping team members with the necessary skills and knowledge to perform their roles effectively and in compliance with cGMP standards.
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Implementation of continuous improvement projects to reduce changeover time between products by 15%.
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Mentoring team in continuous improvement project for the streamline of data extraction for trends of process parameters during multiple batch processing.
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Collaboration with CQV to carry out activities for the implementation of a new freeze thaw unit.