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Sven Nieba is an experienced engineer with a diploma in environmental and hygiene engineering and approximately 20 years in Quality Assurance and Operations within FDA-regulated biopharmaceutical companies. Throughout their career, Sven has held increasing responsibilities, including 16 years in managerial roles, with expertise in quality oversight, product release management, and critical deviation investigations. They have served on site quality councils and leadership teams for over 8 years and have direct interactions with regulatory authorities. Sven's competencies include strong leadership, cross-functional management, and a deep understanding of cGMP requirements.