项目期间汇报给主管维修工程师, 随着项目进展过渡到BAU生产的组织架构
Project phase report to lead maintenance engineer, will update according to business when progress to BAU phase
工作描述简述Brief Job Description
概述工作的目的或角色及其在组织内的价值Summarizes the job’s purpose or role and why it exists in the organization
岗位工作地点在青岛。自动化工程师是具备良好生产流程知识的专业人员，良好的 掌握自动化生产流程相关应用例如MES (PAS-X), LES,PCS7, Historian (OSI PI) and OEE (TrackSys) ，追溯系统，并能够将系统知识通过合理的分级培训转移给到业务团队。自动化工程师能够独立与IT 业务分析员和 全球 业务分析员进行定期沟通， 并负责将问题的后续解决方案与影响与业务达成良好沟通。针对常见设计问题，能够独立提出相关解决方案。 项目建设期间参与项目前期的设计，建造，调试和确认等工作，作为用户代表更好的支持项目组实现青岛pMDI工厂的建设。
进入商业化生产期间，在遵守安全、GMP的前提下,正确、有效的执行自动化系统应用的改进、维护活动，快速响应现场报修需求，确保所有自动化系统处于安全和高效率的运行状态，以支持pMDI工厂生产及供应的核心业务流程,达成领先的SQSCP的绩效。同时不断提高技术能力，就自动化应用方面的问题与内部和外部客户建立高效的沟通。
This role is based in Qingdao and qualified production process knowledgeable person mastering good skills of MES (PAS-X), LES, PCS 7,Historian (OSI PI) and OEE (TrackSys), Traceability system，also has the capability to transit the knowledge to BAU team through appropriate training delivery. The role also be capable of hosting the regular discussion with global IT BA and global GMBR expert for issue tracking and solution. And be able to deliver a good communication with business of the issue’s solution and impact. During project phase involved in project Design、Construction、Commissioning and Qualification as end user to support Global engineering team/Project team to deliver Qingdao pMDI project.
When moving into BAU, To comply SHE and GMP，through appropriate automation system update 、maintenance activities effectively ,quick response to trouble-shooting ,make sure all the automation application system in safe, high-yield manner to support the core business process of pMDI site to achieve top decile performance of SQSCP. Improve the professional capability constantly, communicate with external and internal customer and supplier for automation application issue.
具体职责/任务
Specific Responsibilities/Tasks
13 01 与配料、制剂、罐装、组装、包装的流程执行一线经理和专家以及项目组来总结和可视化现行的生产流程
Work together with dispensing、formulation、filling、A&P process facilitators and SME and project member to summarize and visualize the current production process.
01 根据药品生产质量管理规范和PAS-X可执行批生产记录的理念将生产流程进行系统语言转化,并能实现流程的简化以及标准化。Transfer the production process based on GMP requirements and PAS-X MBR design concept into system design especially in the way of simplification and standardization.
01 与流程执行团队一起共同推进PAS-X系统，以使工厂实现电子批记录和物料追踪
Lead PET to roll out PAS-X system to enable Qingdao site EBR/material flow tracking.
01 与流程执行团队一起共同推进过程控制系统如PCS7，以实现青岛工厂制剂工艺的稳定运行
Lead PET to roll out process control system like PCS7 to enable formulation process of Qingdao site run steadily
01 与流程执行团队一起共同推进追溯系统，以实现青岛工厂产品的可追溯性
Lead PET to roll out traceability system to enable traceability of Qingdao site products
01 与流程执行团队一起共同推进自动化系统的应用, 比如LES、大数据课题Data Historian & Discoverant以及质量系统等。
Can take some sub-stream project tracking responsibilities i.e. LES Big data related-Data Historian & Discover ant and Quality system etc…
01 撰写数字自动化系统方面的SOP和工作指导文档并持续确保最新的版本给到用户
Draft digital & automation system documents such as SOP 、WI and continuously ensure the latest effective version to all of users
01 负责自动化软件的管理、预防性/故障维护活动，并根据GMP,CGMP,SHE和生产的要去对自动化程序进行开发和维护：
Responsible for automation software management 、preventive /restorative maintenance activities,
1、 负责自动化软件及设施的管理和维护
Responsible for the management and maintenance of automation software and facilities
2、 负责自动化系统的升级和改进
Responsible for the upgrade and improvement of the automation system
① 对设备运行进行优化，以提高生产力和稳定性
Optimize equipment operation to improve productivity and stability
② 对新项目新设备进行研究，编写相关的材料（用户需求、规格说明书）
Research on new projects and new equipment, and prepare relevant materials (user, specifications)
3、 负责自动化程序的备份
Responsible for the backup of the automated program
4、 参与或领导新的项目，提出推荐方案，实施解决方案，以确保项目达成预期
Participate in or lead new projects, propose proposals, and implement solutions to ensure that the project meets expectations
5、 编写自动化程序的SOP和工作指导
Write SOPs and work instructions for automated programs
6、 通过培训分享提高团队的技能
Improve the team's skills through training and sharing
01 在进行一切与业务相关活动时都严格遵守公司 GMP、SHE、合规及其与职位和职责相关的支持性政策与标准
Conduct all business activities in compliance with the GMP /SHE/Compliance supporting Policies and Standards related to position and responsibilities
01 日常工作中与带班/生产负责人/流程团队成员紧密协调
Well coordinate with group leader/PF/PCO members in daily operation