南京招聘

职位描述：
? Provide deep technical knowledge of multiple systems (based on assigned area or equipment set) as required to develop or provide oversight to the development of protocols to complete commissioning and qualification of these systems; including but not limited to Installation Verification, Start-up, Functional Testing, and Installation and Operational Qualification.
? Travel as needed to support Vendor FAT activities required to support the commissioning of the system.
? Work collaboratively with project support groups (e.g. automation, construction, engineering) and the end-user representative to resolve non-conformances related to commissioning and qualification of their systems.
? Abide by all safety requirements and procedures pertaining to their role
? Liaise all Document Deliverables and Approvals, the output of Documents will be controlled by the Document Generation Tracker, which will generate Milestones and Durations, of which, the Lead will be measured against.
? Review and approval of all Vendor Documentation
? Liaise to ensure all A&E and Vendor Engineering Lists are loaded and correct within Database Ensure valued input into CQV Schedule and Milestones
? Assist where applicable in Quality Audits for all vendors / suppliers
? Utilize and coordinate review and approval for all execution work for related Systems - all IV deliverables = Walkdowns, Tag Verification, Loop Checks, Static Set to Work (STW), Pre-Start-up Safety Review (PSSR), Dynamic Set to Work (DSTW).
? Review and approval of all Vendor Turnover Packages and Field Turnover Packages against the VDR and to ensure these support the Validation Requirements for the system Lead for Mechanical Completion acceptance and Walkdowns
? Prioritize qualification activities in line with the project schedules and business needs
? Prepare CSRs (Commissioning Summary Reports) for executed documentation
? Ensure all the requirements for the IOQ summary reports are available and the good engineering and documentation practices have been followed throughout.
? Review all vendor and site change controls for impact to the completed testing as required.
? Liaise with QA in close-out of all CQV deviations and exceptions
? Generate Project specific SOP's / other documentation as applicable
? Support CQV and QA programs as required


Requirements:

? BS Engineering (or equivalent experience)
? 5+ years working in Pharmaceutical projects, operations, or manufacturing with deep technical experience in at least one specific area or set of unit operations (e.g. autoclaves, washers, formulation, filling, clean and gray utilities) related to aseptic pharmaceutical manufacturing.
? 3+ years CQ experience
? team work abilities
? Knowledge of GMP’S, regulatory requirements, equipment commissioning and qualification
? Good written and verbal communication skills
? High attention to detail.
? Travel: as per required and approved 举报 分享

Jacobs Engineering Group Inc.是全球最大的工程公司之一，总部位于美国加利佛尼亚州的帕萨迪纳。公司集团成员分布在全球30多个国家和地区，公司拥有超过200个公司集团成员，全球拥有65,000名员工。公司向全球范围内的客户提供多元化的技术、专业和工程建设服务，在2012年度获得了超过100亿美元的收入。

Jacobs Projects(Shanghai) Co. Ltd. 嘉科中国简介：
A world-class contractor serving international companies
服务于国际公司的世界级承包商，在中国涉及的行业有

Architectural 建筑
Pharmaceutical 制药
Chemical / Petrochemical 化工 / 石化
Permanent Shanghai,Zhuhai, Chengdu, Xian, Taiyuan offices
在上海、珠海、成都、西安、太原拥有办公室
300 projects executed in China since 1978
自1978年始在中国执行的项目超过300个
600 bilingual professional employees
中国地区拥有600位员工
Proven project execution capabilities
拥有强大的项目执行力
Close cooperation with Chinese design institutes, Chinese construction companies and local authorities
与中国的设计院、施工单位及地方政府之间密切合作