MSAT 技术转移和工艺验证高级工程师-副主任级工程师

• 负责工艺技术转移：包括新产品引入、工艺差距分析、风险评估以及生产现场技术支持等工作。

• Responsible for process technology transfer, including new product introduction, process gap analysis, risk assessment, and on-floor technical support during manufacturing. · 负责工艺验证活动：包括制定验证方案、开展风险评估、参与执行工艺性能确认（PPQ）、提供生产现场支持并撰写验证报告等。

• Responsible for process validation activities, including developing validation protocols, performing risk assessments, participating in PPQ execution, providing on-floor support, and preparing validation reports. ·负责MSAT相关变更与偏差管理：包括对工艺、物料等变更进行技术评估与影响分析，以及参与偏差调查与根本原因分析工作。

• Responsible for MSAT-related change control and deviation management, including conducting technical assessments and impact analyses for process and material changes, as well as participating in deviation investigations and root cause analysis. ·参与MSAT原液实验室的工作（如需）。

• Participated in the MSAT DS lab work (if needed). ·作为MSAT代表参与并支持客户来访、客户审计和官方审计。

• Act as the MSAT representative to participate in and support client visits, client audits, and regulatory inspections. ·参与团队管理：包括团队建设、人员发展、资源管理及日常运营等。

• Participate in team development, personnel capability building, resource management, and daily operational oversight. · 配合部门领导完成其他MSAT相关工作。

• Assist function head to finish other MSAT related assigned work.

1.1熟悉微生物发酵或蛋白纯化工艺开发或熟悉 GMP 生产的要求，了解临床和上市申报制度和流程。 Solid professional knowledge of microbial fermentation or purification, or familiar with the requirements of GMP production。 Understand IND and BLA filing declaration system and process. 1.2 精通微生物发酵或蛋白纯化工艺，熟悉GARA、FMEA等质量工具，熟悉工艺验证，成功主导PPQ项目案例。 Expertise in microbial fermentation or protein purification, proficiency in QbD/DOE, experienced in process validation with proven PPQ leadership. 1.3 熟悉FDA/EMA/NMPA对生物制品工艺验证的法规要求，具备应对审计实战经验。 In-depth knowledge of FDA/EMA/NMPA regulations for biologics process validation; hands-on audit experience. 1.4 出色的英文沟通能力（书面及口语），能独立主导跨国客户会议及技术交流。 Fluent in English (written & spoken), capable of leading global client meetings and technical communication. 1.5 良好的团队协作和管理能力。 Good teamwork and management skills. 1.6 问题解决：对复杂工艺问题有快速定位和系统性解决能力。 Problem-Solving: Rapidly diagnose and systematically resolve complex technical challenges.