Field Engineer-MFG20 配液方向

Responsibilities

1. 负责按GMP要求进行一次性系统的操作与清洁，进行培养基、缓冲液的配制。

 Be responsible for the operation and cleaning of disposable system according to GMP requirements, and preparation of culture medium and buffer solution

2. 负责按GMP要求进行洁净区内的清洁消毒工作，如清场清洁和设备表面清洁等。

 Be responsible for cleaning and disinfection in the clean area according to GMP requirements, such as site clearance cleaning and equipment surface cleaning

3. 负责生产用物料车间内领用、复核、管理工作。

 Be responsible for receiving, reviewing and managing the materials for production workshop

4. 负责SOP/MBR等文件的起草/升版。

 Responsible for drafting/upgrading SOP/MBR etc.

5. 参与相关变更，偏差的调查执行，以及审计整改活动的执行。

 Participate in the investigation and implementation of relevant changes and deviations as well as audit and rectification activities

6. 负责配合部门对其他有需求的员工进行相关培训，并按时完成个人的培训任务。

 Be responsible for cooperating with the department to provide relevant training for other employees in need, and complete personal training tasks on time

7. 需要参与厂房和设备验证相关活动

 Participate in the qualification activities of facility and relative equipment.

8. 负责配合部门内其他GMP工作的开展，例如logbook复核、BPR的审核等。

 Be responsible for cooperating with other GMP work within the department, such as logbook review, BPR review, etc.

Requirements

1. 专科及以上学历，生物、化学、医药工程等相关专业，或具有同等工作经验的人员，有2年及以上工作经验者优先。

 College degree or above, major in biology, chemistry, pharmaceutical engineering or other related disciplines, or personnel with equivalent work experience, 2 years or more experience preferred

2. 具有培养基/缓冲液配制等GMP生产操作的相关知识或经验。

 Knowledge or experience in GMP manufacturing operations such as media/buffer preparation

3. 具有较好的沟通能力和理解能力。

 Good communication and comprehension

4. 工作积极向上并具有良好的学习能力。

 Positive work and good learning ability

5. 熟练使用Word、PPT、Excel、Visio等办公软件。

 Be familiar with office software such as Word, PPT, Excel and Visio