上海招聘

PSC China – Computerized System Validation Engineer

KEY RESPONSIBILITIES:
Work as part of multi-disciplinary validation teams responsible for validation of automated equipment, distributed control systems and computerised controls in new and modified pharmaceutical and life science facilities.


QUALIFICATIONS:
This position requires a Degree in Engineering / Life Sciences, or equivalent industry experience.

RESPONSIBILITIES:
? Conducting System Compliance Assessment
? Developing and managing GxP system lifecycle documentation, including Validation Plans, User Requirements Specifications, Functional and Design Specifications, Testing Protocols (IQ/OQ/PQ), Traceability matrix, Validation Reports, SOPs, Change Control Documentation, and Risk assessment reports.
? Reviews completed protocols for completeness, cGxP compliance and data acceptability; compiles final data package.
? Initiate and enforce necessary improvements and corrections to established systems and processes via mitigation plans and change control.
? Establish priorities and schedule activities to ensure timelines and milestones are met.
? Reports progress and issues to team lead in an effective manner.
? Independently follows-up and resolves comments, deviations, and technical issues.

EXPERIENCE:
The ideal candidate will have 5 years or more experience in support and installation of MES or Distributed control systems or in commissioning and /or validation automated equipment and systems, preferably with experience in one or all of the following: DeltaV, LIMS, Siemens PCS 7, SAP and Werum MES.
We will consider experienced candidates with in depth knowledge of the above systems who have limited validation experience.

Ideally the candidate will have:
? A high level of technical written and oral communication - English and Mandarin
? A high level of computer literacy / word processing skills
? An ability to identify and analyse technical problems
? An ability to work proactively with minimal levels of supervision
? A sound understanding of GMP applications and regulatory requirements within the pharmaceutical industry
? Experience during the design / start up of Greenfield Manufacturing Facilities (Bulk API / Biotech / Secondary Pharmaceutical)
? Experience working under Quality Systems
? A customer-oriented work-ethic, able to work with all levels of client organisations
? Flexible work approach
? Experience in either Werum MES, or Siemens PCS 7 or SAP
? Willing to travel

Due to highly respond, we will only approach to qualified candidates.

PSC生物技术(北京)有限责任公司在全球致力于推广和提升世界范围内医药和医疗器械行业的GMP水平，是全球高端GMP认证的引领者和传播者。 时至今日，美国医药服务有限已经成为全球首屈一指的专业化FDA、EMEA认证顾问公司，除美国洛杉矶总部外，相继在美国和世界其它城市成立分公司，以雄厚的技术力量覆盖全球，跻身成世界最具专业、最大的医疗行业咨询服务机构和原料药采购代理机构。公司从1996年成立至今，与北美、欧洲、亚洲的众多知名制剂企业建立了良好的合作关系，不仅为其旗下制剂、医疗器械产品提供验证及质量系统、国际认证、国际药政政策遵守等服务，更是囊括了产品进出口及采购和销售等多方面服务。

公司将为录用人才提供良好的职业培训，具有市场竞争力的薪酬福利待遇，有意者请发邮件至公司邮箱，并在Subject 栏注明应聘职位。


更多公司详情请参阅www.biotech.com或www.psc-asia.com

PSC Biotech Corporation is a global, employee owned, life sciences consultancy that performs projects and staff augmentation in the following disciplines: Engineering, Information Technology, Technical Services, Validation, Compliance, Regulatory Submissions, Clinical, Project Management and Quality Assurance. PSC Biotech, incorporated in 1996, has been performing projects globally for over 15 years.

PSC Biotech has over 358 customers in 23 different countries around the world. PSC Biotech is organized into three primary Business Units:
1. Professional Services
2. Life Sciences Software and IT (Enterprise)
3. Life Sciences Hardware (Equipment and Instruments)
PSC Biotech has offices in North America, Asia and the Middle East. We are the world's largest specialty biotech life sciences consultancy.

Company provides competitive compensation and benefits to hired employees.

Know more about PSC, please enter www.biotech.com / www.psc-asia.com.