上海招聘

Responsibilities:
1. Completing work assignments as specified by the Validation Project Manager.
2. Providing timely updates to the Validation Project Manager.
3. Adhering to the proper site safety practices; wearing adequate safety equipment when required.
4. Completing timesheets and expense reports in a timely manner.
5. Working in a biotech/pharmaceutical environment as a consultant/contractor for various clients of PSC.
6. Working closely with client's employees on various projects and various GMP facilities to help client with validation issues.
7. Learning new ideas, techniques and systems.
8. Commuting to PSC clients' manufacturing for validation projects.
9. Keep client’s proprietary information confidential.
10. Writing Validation Protocols such as IQ, OQ and PQs
11. Executing Validation Protocols such as IQ, OQ and PQs
12. Calibrating Thermocouples for Temperature Mapping Studies
13. Calculating and interpreting of collected data from validation studies.
14. Generating Validation Summary Reports and Standard Operating Procedures (SOPs)
15. Create Validation Risk Assessments
16. Mentoring junior staff and interns

Requirements
1. Diploma or degree qualification preferred; B.S in Chemical, Mechanical, or Electrical Engineering (preferred) or Life Sciences degree.
2. Knowledge of GMP facilities and cGMP requirements.
3. A minimum of one to five years of GMP experience in a biotech or sterile pharmaceutical manufacturing environment, or the equivalent, is desired.
4. Prior work in maintaining GMP biotechnology and/or sterile process equipment is required is desired.
5. Proficient in computer skills and MS Office applications
6. Knowledge of process control systems (PLC, DCS and/or SCADA) is desired.
7. Knowledge of validation test instruments such as Kaye Validator is desired.
8. Excellent written and verbal communication skills
9. A demonstrated ability to work well in a team environment.
10. Excellent written and spoken English communication skills
11. Well presented

PSC生物技术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，美国医药服务有限公司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、***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.

To know more about PSC, please visit www.biotech.com / www.psc-asia.com.