技术服务工程师-无菌保证

该岗位主要工作为协助工厂无菌保证团队完成无菌保证相关文件的编写，审批流程跟进。协助团队整理相关数据与记录并起草相关报告、完成偏差调查相关的信息收集与变更管理。
The primary responsibilities of this position include supporting the site’s TS/MS SA team by preparing and revising sterility assurance–related documents, as well as tracking and coordinating the associated approval workflows. The role will further assist in compiling and organizing relevant data and records, drafting preliminary reports, and supporting the collection of information required for deviation investigations and change control activities.
了解生产无菌注射剂产品相应的科学原理，包括设备、无菌工艺和容器密闭系统之间的相互作用。
Understand the scientific principles required for manufacturing parenteral drug products, including the interactions between equipment, aseptic processes and container closure systems.
了解无菌注射剂产品的生产工艺及对潜在的微生物，内毒素和颗粒物的污染的控制。
Understand parenteral products manufacturing processes and associated controls with respect to the potential for introduction of microbial, endotoxin and particulate contamination.
准备文件，对相关技术文件如：变更控制，法规文件，偏差调查，验证方案和验证报告，标准操作规程，工艺流程文件和验证总计划的准备提供支持。
Prepare and provide support for preparation of relevant technical documents, as required, such as: change controls, regulatory submissions, deviation investigations, validation protocols and summary reports, procedures, PFDs, and VMPs.
监控并在实际环境和人员监测上对已建立的基于统计学基础的指标进行适当回应，评估潜在风险。
Monitor and appropriately react to established statistically based metrics in real-time environment and personnel monitoring to assess potential risk.
实施以下策略：APS，过滤验证，EMPQ，消毒，灭菌，去热原，防渗漏管控，手套管控，更衣管理，生物颗粒物表征，清洁验证（微生物方面），消毒剂验证和容器密闭性验证。
Implements the strategies of APS, Filtration Validation, EMPQ, Sanitization, Sterilization, Depyrogenation, Leaks Mngt, Glove Mngt, Gowning, Biological Particle characterization, Cleaning validation (microbiological aspects), validation of sanitizing agents and Container Closure Validation.
准备与无菌保证相关的EMPQ / PQ / APS / PV / QRM /法规文件
Prepares EMPQ / PQ / APS / PV / QRM / Regulatory documents relating to aspects of Sterility Assurance.
支持持续改进项目。
Support CI projects.
遵守HSE各项管理流程，履行安全生产职责要求。
Follow various HSE management procedures and fulfil the work safety responsibilities.
任职要求：
遵守所有的安全政策、标准和准则。
Adherence to all the safety policies, standards and guidelines.
理解GMPs及国内适用的标准。
Understanding of GMPs and applicable internal standards.
技术写作技巧。
Technical writing skills.
良好的书面和口头英语沟通能力。
Good and strong written and oral English communication skills.
良好的团队合作能力和人际交往能力。
Good teamwork and interpersonal skills.
良好的计算机技能。
Good computer skills.
良好的分析思考能力，多重任务处理，解决问题的能力。
Good skills in analytical thinking, multi-tasking and problem-solving.
良好的管理、项目管理能力，有能力影响并引导项目。
Good skills in leadership, project management, ability to influence and lead projects.
一天8小时-周一到周五。
8 hours’ days – Monday through Friday.
可能会被要求加班。如是工艺团队成员，能及时应对下班以后生产出现的问题。
Overtime may be required. Available off shift to respond to operational issues if as Process Team rep.
申请人将在无菌生产的各个区域工作。有一些潜在的过敏原存在。
Applicant will work in various areas within the Parenteral Site. Some Allergens are present.