锦鲤求职岗位描述
Key Responsibilities:
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.
负责MSAT原液实验室的日常管理。
Responsible for the daily operation and management of the MSAT DS lab.
作为MSAT代表参与并支持客户来访、客户审计和官方审计等，包括厂房及MSAT实验室相关内容。
Act as the MSAT representative to participate in and support client visits, client audits, and regulatory inspections, including topics related to the manufacturing facility and the MSAT laboratory.
负责河北MSAT团队管理：包括团队建设、人员发展、资源管理及日常运营等。
Responsible for managing the Hebei MSAT team, including team development, personnel capability building, resource management, and daily operational oversight.
Requirements:
硕士及以上学历，生物、化学、制药工程等相关专业背景，或具有同等经验的资深专业人士。
Master’s degree or above in Biology, Chemistry, Pharmaceutical Engineering, or a related discipline. Experienced professionals with equivalent qualifications will also be considered.
拥有10年以上相关领域工作经验，以及4年以上团队管理经验。熟悉原液生产工艺的关键执行要点与控制原理，掌握工艺验证的基本框架，熟悉 GMP 质量体系。
More than 10 years of relevant industry experience and over 4 years of team management experience. Strong understanding of key factors and control principles of DS manufacturing processes. Well-versed in the fundamental framework of process validation and familiar with the GMP quality system.
具有临床生产或商业化生产阶段的工艺变更和工艺验证经验。具备优秀的沟通能力和结构化思维能力。具备良好的英文沟通、组织协调和技术文档撰写能力。
Candidates with experience in process changes and process validation during clinical or commercial manufacturing phases are preferred. Demonstrates strong communication skills and structured thinking. Possesses solid English communication abilities, including meeting facilitation and technical documentation writing.
责任心强，具备快速学习的能力和意愿。具有优秀的团队协作精神，工作态度积极主动。
Highly responsible, with strong learning capability and motivation. Exhibits excellent teamwork spirit and maintains a proactive and positive working attitude.