Manufacuturing science Engineer

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Job Description

Job Title: Manufacturing Science Engineer

Location: Tianjin, China

About the Role:
Ensure the smooth execution of the “China for China” new product introduction and transfer project at Takeda’s Tianjin plant.

How You Will Contribute:

Technology Transfer: Participate in new product technology transfers, including process research, evaluation, and implementation; draft related technical documents. Process Optimization and Improvement: Analyze production processes, propose technical improvement plans, and optimize processes to enhance production efficiency and product quality. Problem Analysis and Resolution: Troubleshoot issues in production, provide technical support, and quickly resolve technical problems related to processes and equipment. Document Preparation: Write and review relevant technical documents, such as validation protocols, SOPs, deviation reports, ensuring compliance with GMP and regulatory requirements. Validation Support: Support process and cleaning validation efforts, ensuring compliance in process and product validations. Cross-Department Coordination: Collaborate with R&D, quality, production, and other departments to ensure smooth technical communication and support. Regulatory Compliance: Ensure technical solutions and operations align with pharmaceutical regulatory requirements and internal company standards. Audit Support: Assist with the completion of internal and external audits and address corrective and preventive actions in a timely manner.

What You Bring to Takeda:

Education: Bachelor’s degree or above, with a background in pharmacy or chemistry. Work Experience: At least 3 years of experience in process technology or technology transfer in pharmaceutical companies, particularly in packaging technology transfer; familiar with validation and technical transfer documentation. Professional Knowledge: Strong GMP foundation; familiar with pharmaceutical production and technology transfer processes with deep knowledge of regulations to ensure compliance in technical transfers. Skills: Strong analytical and problem-solving skills, excellent organizational and team collaboration abilities. English Proficiency: Proficient in English (listening, speaking, reading, writing) with the ability to communicate independently and smoothly with international collaborators.

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