长沙招聘

职责描述：

Waters Corporation's Professional Services Organization is comprised of highly skilled, motivated and customer focused professionals that partner with customers to ensure successful utilization of Waters’ product suite. As CSV Specialist working for an industry leader, you will be committed to delivering Waters’ legendary service to our customers who utilize our scientific instrumentation and software. In this role, you will have the opportunity to provide (professional and/or technical) expertise on Waters' innovative product suite for multiple customer laboratories spanning across the Pharmaceutical & Life Sciences, Chemical Materials, Clinical, Food, Environmental, Forensics, Academia and Government industries.

任职要求：

? Develop and author Computer System Validation deliverables for regulated applications: Validation Plans, Requirement Specifications, various levels of software testing scripts (IQ, OQ, PQ), Traceability Matrix, and Validation Reports.

? Write, review and approve documents to support computerized system processes.

? Perform quality review and approval of documents supporting computer system validation processes.

? Act as subject matter expert for 21 CFR Part 11 compliance, Part 58, Part 110, Part 211, Part 820 regulations.

? Support the validation process of Empower 3 Enterprise application and modules: Method Validation Manager, GPC/SEC, Dissolution, and System Suitability.

? BS/BA in Computer science, Life Sciences or related field of study 

? Minimum of 2 years experience in developing and authoring computer systems validation deliverables for regulated applications 

? Experienced working within a regulated environment for the Pharmaceutical and/or Medical Device industry

? Thorough knowledge of US CFR 21 Part 11, Part 58, Part 110, Part 211, Part 820 regulations

? Experience in analytical or QC laboratories utilizing Empower 3 Enterprise is strongly preferred

? Experience with automated software testing tools, QA Auditing and Corrective and Preventative Action programs are a plus

? Direct knowledge of computer systems validation

? Project management skills preferred

? Travel is required, includes local and overnight

? Must possess a strong customer focus 

? Interpersonal savvy, communicate with different expertise levels appropriately and change your approach to meet customers’ needs

? Personal sense of integrity and trust

? Effective team participation and collaboration within Waters and a customer environment

? Effective time management skills 

? Excellent verbal and written communication skills

沃特世公司创始于1958年，是全球领先的分析实验室技术开发商及制造商。沃特世专注于推动当今前沿分析实验室技术的应用，包括液相色谱、质谱和相关化学耗材及信息化解决方案。

自上世纪80年代进入中国以来，沃特世的规模与实力与日俱增，在大陆及香港、台湾均设有运营中心，拥有五百多名本地员工，并在上海、北京、广州、成都设立实验中心和培训中心。

自2003年成立沃特世科技（上海）有限公司以来，今天的中国已成为沃特世全球营收仅次于美国的第二大市场。作为分析科学家的理想合作伙伴，沃特世始终坚持提高本地技术能力、支持本地技术人才培育，并推动制药、食品安全、健康科学、环境保护等相关行业标准和法规的建立和完善。

凭借出众的人才与全球布局，沃特世已经为其商业合作伙伴创造了显著的价值，并致力于满足广大中国消费者对更美好生活的需求。


About Waters China

Founded in 1958 in the U.S., Waters Corporation is a leading developer and manufacture of analytical laboratory technologies. The company is focused on advancing the most leveraged laboratory technologies in use today: liquid chromatography, mass spectrometry and related chemistry consumables and informatics solutions..

Having established a regional presence in China since 1980s, Waters has grown in size and strength with more than 500 local talents located in five operating centers: Shanghai, Beijing, Guangzhou, Chengdu and Hong Kong.

Through Waters Technologies (Shanghai) Limited founded in 2003, China has become Waters' second largest market worldwide as measured by revenue, only behind the United States. As a preferred partner of analytical scientists, Waters will continue to enhance local technological capabilities, support training for local technical talent and stimulate development of the standardization and regulation of Pharmaceutical, Food, Health Science, Environment Protection and all related industries.

Waters has the talent and global footprint to create significant value to our business partners as well as to serve the Chinese people's evolving needs for a better life.

The opportunities are now available for you to challenge yourself in your career!