岗位职责： 61参与工艺技术转移、设施/工艺适配性评估以及新产品引入评估 61Participate in process technology transfer, facility/process fit assessment, and new product introduction (NPI) evaluations. 61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 61Responsible for drafting and reviewing process transfer documentation, including gap analysis and risk assessment, process transfer protocols, bills of materials (BOM), process flow diagrams, process transfer reports, etc. 61负责工艺变更的技术评估与影响分析 61Responsible for conducting technical assessments and impact analyses for process changes. 61参与场地、设备及物料变更的技术评估与影响分析 61Participate in technical assessments and impact evaluations related to site, equipment, and material changes. 61参与与工艺相关的偏差调查 61Participate in the investigation of process-related deviations. 61参与生产过程中的问题排查，协助工艺流程优化与持续改进 61Support troubleshooting during manufacturing operations, assist in process optimization, and contribute to continuous improvement initiatives. 61参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 61Participate in on-floor execution of selected critical unit operations, and support the design and execution of associated studies. 61参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 61Participate in internal and external project meetings, and facilitate effective communication with cross-functional teams and ******s. 任职要求： 61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 61Bachelor’s degree or above in biology, chemistry, pharmaceutical engineering, or related disciplines. Equivalent relevant experience may also be considered. 61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 61Experience in either upstream or downstream processes, with familiarity in bioreactor control or purification unit operations and their basic control parameters. Experience in cell culture or purification R&D or manufacturing is required. 61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 61Basic understanding of GMP principles, with the ability to perform work within a regulated quality system, ensuring compliance with data integrity and traceability requirements. 61具备良好的沟通能力与结构化思维能力 61Strong communication skills and structured thinking. 61具备良好的英文沟通、会议组织及技术文档撰写能力 61Proficient in English communication, meeting coordination, and technical writing.