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Merck KGaA
Responsible for new products transferring, technical improvement such as site expansion project management, SU new products transferring in, Hazard analysis of new product, material localization, new process & equipment design, installation, validation & qualification, technical improvement to support site business growth and new products commercial launch.Be in charge of new project management to ensure project meets each milestone on time with high quality and project cost within budget.Be responsible for new product technical related such as readiness of Drawing / BOM / TP, SOP / work instruction development, manufacturing data in SAP system, new products design and validation, employee technical training & qualification, etc.Timely Technical Transfer of down filling, manufacturing technology from other global plants to support meeting production & customer demand. Initiate continuous improvement projects to drive cost saving, quality improvement such as new equipment development, current process / equipment upgrading, automation, etc. Responsible for assuring compliances to all regulatory requirements no matter for project phase new products transferring in or new process / equipment development - ISO, EHS, etc. Work with PSM & quality team for raw material localization, key supplier development & maintain relationship to improve material quality standard, reduce cost & delivery lead time.As project contact window, ensure good communication within site function team, giving site, commercial and other supporting function.Evaluate CAPEX required and interaction with E&T team and OEM. Support plant - wide strategic plan programs and activities.Other assigned tasks which are required by site leader.Organizing cross functional meeting with Global team to have smooth product transfer taking all taxation/regulatory /statutory /Change Management compliances into consideration. Who You Are:Requires a B.E/M. Tech. or equivalent, preferably in Chemical /Mechanical engineering, 10-12 years ' experience in technical or manufacturing process in pharmaceutical, biotechnology/Chemical -Fine/specialty/API or comparable environment.Technical & Professional Knowledge:Rich experience in new products transferring in, project management, process technical improvement, material localization, Process equipment Design etc.Good communication and interpersonal skill Lean six sigma knowledge & experience, continuous improvement mindset.GMP and product design knowledge
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