上海招聘

Project Manger

Working closely with US Manangement Rep. and project lead. Reporting work to them as well. Supervising and mentoring junior validation engineer and interns.

Support validation and regulatory submission projects as appointed by management.Good project experience is must.

Responsibilities

Responsibilities include supervision of assigned project staff.
Providing cGMP oversight for cGMP systems (e.g. bioreactors, chromatography systems, buffer/media preparation equipment, CIP/SIP systems, aseptic filling machines and the automated controllers, etc.).
Maintaining project schedule, project budget and progress reports to the client.
Acting as a subject matter expert on several process systems, instructing staff on proper operation of equipment and creating cGMP documentation (SOPs, qualification/validation protocols and final reports).
Hands on responsibility for commissioning of new systems, review of functional and detailed specifications, FATs/SATs, qualification, validation, deviation investigations and working with outside equipment/service providers.
Ensuring proper site safety practices are followed by PSC and contract staff; and ensure adequate safety equipment is available for PSC and contract staff.
Ensuring timesheets and expense reports are completed properly and submitted into PSC's time and expense systems.


Requirements

Diploma or degree qualification preferred; B.S in Chemical, Mechanical, or Electrical Engineering (preferred) or Life Sciences degree.
A minimum of six years of GMP experience in a biotech or sterile pharmaceutical manufacturing environment, medical device manufacturing environment, or the equivalent, is required.
Project management experience is required.
Prior work in maintaining GMP biotechnology and/or sterile process equipment is required.
Excellent organization and project management skills
Proficient in computer skills and MS Office applications
Knowledge of process control systems (PLC, DCS and/or SCADA).
High energy and attention to detail.
Excellent written and verbal communication skills
A demonstrated ability to work well in a team environment.
Good leadership skills
Ability to work independently and as part of a team, self-motivation, adaptability, and a positive attitude
Excellent written and spoken English communication skills.
Well presented
Team player

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.