•Works with customer IT representatives, end users, clients and field application specialists, product representatives, and field engineers to development CSV plans.
与客户IT代表、最终用户、客户和现场应用专家、产品代表和现场工程师一起制定CSV的计划。
•Works with customers and other project team members to create, modify and finish validation deliverables (e.g. Validation Plan, Design Review Report, Test Plan & Reports, IQ/ OQ Protocol and Reports, etc.) to meet specific customer needs.
与客户和其他项目团队成员一起创建、修改和完成验证交付成果(如验证计划、设计评审报告、测试计划和报告、IQ/ OQ协议和报告等)，以满足客户的特定需求。
•Provides GXP instrument and software validation consulting services to customers based on the established Professional Services project management methodology.
根据已建立的专业服务项目管理方法，为客户提供满足GXP要求的仪器和软件验证咨询服务。
•Works with customer IT representatives, end users, clients and field application specialists, product representatives, and field engineers to solve validation failures, and writes proposed solutions and remedy responses based on customer requirements and business needs.
与客户IT代表、终端用户、客户和现场应用专家、产品代表和现场工程师一起解决验证故障，并根据客户需求和业务需求编写建议的解决方案和补救响应。
• Develops “best practices” for various phases of validation project lifecycle and trains the customer based on training materials developed as part of a validation project.
为认证项目生命周期的不同阶段进行优化，并根据作为认证项目的一部分开发出来的培训材料培训客户。
•Reports task and/or project status to the project manager(s) as needed by the project manager(s).
根据项目经理的要求，向项目经理报告任务和/或项目状态。

任职要求：
•Bachelor or above degree in Chemistry/Pharmacy/Life sciences/Computer Sciences, or related field. Master degree preferred.
学士或以上学历，化学/制药/生命科学/计算机科学或相关领域。硕士学位优先考虑。
•Familiar with HPLC, GC, ICP-MS, LCMS, GCMS and other conventional chemical analysis instruments operation.
熟悉HPLC、GC、ICP-MS、LCMS、GCMS等常规化学分析仪器的操作
•Strong communication and presentation skills.
较强的沟通及表达能力。
•Collaborates well, while also can deal with conflict resolution
良好的合作能力，同时也有处理冲突的能力。
•Diligent with attention to detail
注重细节
•Proficiency in both spoken and written English. Good command of MS office software application
熟练掌握英语口语及书面表达，熟练应用微软办公软件
•Understand related regulatory requirements and industry standards,such as 21 CFR Part 11/210/211, Annex 11 of EU GMP, Appendix I of CFDA GMP, GAMP 5, and ICH Q9/Q10.
对于相关的法规要求和行业标准有一定的了解，如21 CFR Part 11/210/211，欧盟GMP Annex 11，中国GMP Appendix I，GAMP 5和ICH Q9/Q10