上海招聘

职位描述：
Responsibilities:
1. Draft procedure and report of equipment/instrument qualification.
2. Perform the execution of equipment/instrument qualification.
3. Coordinate with ENG department in terms of validation instrument calibration.
4. Responsible for validation/qualification annual review, requalification, deviation, change control, investigation, CAPA, and/or the other GMP activities related to facility, equipment and cleaning. Able to write change controls, deviations and CAPAs in a logical and clear manner and follow up progress.
5. Support in process/analytical method/cleaning validation coordinating with other related department/team.
6. Prepare monthly/weekly summary report for equipment/instrument qualification related activities.
7. To communicate with and assist different group or department in a timely manner to fulfill the work assignment with efficiency.
8. Conduct the work assignments in compliance with cGMP regulations whenever applicable.

Qualification:
1. BS degree in chemical, mechanical, electrical engineering or equivalent practical working experience.
2. A minimum of two years GMP experience in a biotech or sterile pharmaceutical manufacturing environment.
3. Knowledge of cGMP requirements.
4. Knowledge of validation test instruments such as Kaye, Fluke, TESTO, and air sampler.
5. Knowledge of facility engineering/design such as HVAC system, clean facility is a plus.
6. Solid experience in process/analytical method/cleaning validation is highly preferred.
7. Proficient in computer skills and MS Office applications.
8. Excellent written and verbal communication skills.
9. Excellent written and spoken English communication skills is preferred. 举报 分享

药明巨诺是一家专注于细胞免疫治疗、处于临床阶段的创新型生物科技公司，站在巨人的肩膀上，充分结合了美国巨诺公司国际领先的技术优势以及药明康德集团强大的本土经验。

定位与愿景：
致力于以创新为先导，成为细胞免疫治疗引领者
 - 对患者：用最前沿的细胞免疫治疗技术、高品质的产品，造福中国及全球患者
 - 对行业：与国内外合作伙伴携手开展多方位合作，共建中国细胞免疫治疗的行业规范与生态系统，打造国际领先的细胞免疫治疗技术创新平台