工艺工程师

备注：此岗位是罗氏诊断外包岗，但福利待遇跟正式员工一致，薪资架构为base+补贴*13薪+年终奖
Job Summary职位概述:
The job holder is as technical leader and SME for production system and equipment from the operation side.
该职位是生产系统与设备的技术主管和专家
The job holder will lead or support a new project for Compounding，filling and packaging process，equipment and system.
该职位将领导或支持配制，灌装和包装流程，设备与系统的新项目。
The job holder should be capable to develop a detailed knowledge of Production processes, and be capable to identify the critical process control points for production quality and efficiency
该人员应具备对产品生产过程的详细知识，并能够为生产质量和效率识别出关键过程控制点。

Main Tasks & Responsibilities主要工作职责 :

- As technical SME of production process, be responsible for keeping optimization on the process & system.
作为生产流程技术专家，负责持续优化流程和设备系统
- Coordinate or support on equipment FAT, SAT, IQ/OQ, PQ, and process validation. Ensure production equipment, processes are qualified or validated.
协调或支持生产设备的FAT、SAT、IQ/OQ、PQ工作，以及工艺验证。确保设备和流程的合格验证状态
- Working on NC and ECR tasks (e.g. OOS, NC, CAPA, ECR coordinator)
负责偏差和变更（例如：超标数据，偏差，预防纠正以及变更的协调）

- Assessment and managing of product quality data (Trend analysis). Trigger correct & preventive action and improvement project for quality compliance and operation optimization.
评估和管理生产质量数据（趋势分析），并发起相应的纠正和预防措施以及质量改进和运营优化的改善项目。
- Support the team buildup, induction, training & qualification and development within the department. Work out training materials with the reference to SOP, technical and production documents. Technical training for Manufacturing technicians
支持团队建设，新员工融入和培训认证，以及部门内部发展。根据相关的SOP，技术文件和生产文件，准备培训材料。为生产团队提供技术培训。
- Other tasks assigned by head of department
部门领导分配的另外的任务。