WuXi Biologics sa jobs (salary & requirements)

岗位职责：
• 参与工艺技术转移、设施/工艺适配性评估以及新产品引入评估
• Participate in process technology transfer, facility/process fit assessment, new product introduction (NPI) evaluations.
• 负责编写和审批工艺转移相关文件，包括差距分析与风险评估、工艺转移方案、物料清单、工艺流程图及工艺转移报告等
• Responsible fdrafting reviewing process transfer documentation, including gap analysis risk assessment, process transfer protocols, bills of materials (BOM), process flow diagrams, process transfer reports, etc.
• 负责工艺变更的技术评估与影响分析
• Responsible fconducting technical assessments impact analyses fprocess changes.
• 参与场地、设备及物料变更的技术评估与影响分析
• Participate in technical assessments impact evaluations related to site, equipment, material changes.
• 参与与工艺相关的偏差调查
• Participate in the investigation of process-related deviations.
• 参与生产过程中的问题排查，协助工艺流程优化与持续改进
• Support troubleshooting during manufacturing operations, assist in process optimization, contribute to continuous improvement initiatives.
• 参与工艺验证中部分关键单元操作的现场执行，及支持性研究的设计与实施
• Participate in on-floexecution of selected critical unit operations, support the design execution of associated studies.
• 参与项目相关的内外部会议，负责与相关职能部门及客户的沟通与协调
• Participate in internal external project meetings, facilitate effective communication with cross-functional teams clients.


任职要求：
• 本科及以上学历，生物、化学、医药工程等相关专业，或具备同等工作经验者
• Bachelor’s degree above in biology, chemistry, pharmaceutical engineering, related disciplines. Equivalent relevant experience may also be considered.
• 具备上游或下游工艺经验，熟悉细胞反应器控制或纯化单元操作及其基本控制参数；具有细胞培养或纯化工艺研发或生产经验
• Experience in either upstream downstream processes, with familiarity in bioreactcontrol purification unit operations their basic control parameters. Experience in cell culture purification R&D manufacturing is required.
• 具备GMP基础知识，能够在受监管的质量体系下开展工作，确保活动符合数据完整性和可追溯性要求
• Basic understanding of GMP principles, with the ability to perform work within a regulated quality system, ensuring compliance with data integrity traceability requirements.
• 具备良好的沟通能力与结构化思维能力
• Strong communication skills structured thinking.
• 具备良好的英文沟通、会议组织及技术文档撰写能力
• Proficient in English communication, meeting coordination, technical writing.