清洁验证工程师

KEY ACCOUNTIBILITIES

1. 01

   配合生产部完成清洁工艺的开发和参数的摸索，指导清洁验证，清洁确认和生产工艺验证等相关规程的建立和持续改进。 Cooperate with the MFG department to complete the development of cleaning process and explore the parameters, Guide the establishment and improvement of cleaning procedures and process validation procedure.

2. 02

   建立和执行新产品引入阶段的可清洁性评估规程 Establish and implement the evaluation procedures for product cleanability and products change over when new products are introduced.

3. 03

   主导清洁验证的实施，启动与清洁验证相关变更；参与验证过程中偏差的调查及分析。 Lead the implementation of cleaning validation, Initiate change control of cleaning validation related, involve investigation and analysis for deviations occurred during validation.

4. 04

   负责清洁验证、工艺验证相关管理规程的制定、修订及培训。 Responsible for the formulation, revision and training of management procedures related to cleaning validation, process validation.

5. 05

   起草和审核清洁验证计划，组织协调验证工作的有序进行。 Develop and review the clean validation plan Organize and coordinate the implementation of validation in order.

6. 06

   起草相应清洁验证方案和报告,审核工艺相关验证方案和报告（比如培养基模拟灌装验证、工艺性能确认PPQ等），确保所起草的文件满足现行GMP法规指南及工厂验证规程的相关要求。 Draft clean validation protocol and report, Review process related validation protocol and report (such as medium filling validation, process performance

PPQ, etc.), Ensure the drafted documents meet the requirements of current GMP regulations, guidelines and factory validation procedures.

7. 07

   参与厂房公用设施设备确认、计算机化系统验证、运输验证以及再确认/再验证相关工作。 Participate in facility, utility equipment qualification, computerized system validation, transportation validation and revalidation / revalidation.

8. 08

   配合客户及各类官方GMP审计工作, 负责审计问题答复及整改。 Cooperate with customers and all kinds of official GMP audit, be responsible for the reply and rectification of audit problems.

9. 09

   积极完成上级领导临时安排的工作。 Without undue prevarication for the temporary work arrangement. REQUIREMENTS: 岗位要求：

10. 01

    本科及以上学历，制药、生物工程或相关专业，至少5年以上制药和生物制药行业生产及验证经验。 Bachelor's degree or above, in pharmacy or biological engineering or related discipline, At least 5 years production and validation experience in pharmaceutical and biopharmaceutical industry.

11. 02

    良好的合作和沟通技能和影响力；有丰富的确认和验证知识和经验，具有生物制药（单抗、病毒、微生物、mRNA生产）清洁验证从业经验的优先考虑。 Strong collaboration, communication and influence skills; Good knowledge and experience in qualification and Validation, Experience in biopharmaceutical（Mab, virus, microorganism, mRNA production）cleaning validation is preferred.

12. 03

    良好的英语读写和沟通能力。 Good English skills in reading and writing and communication as well.

13. 04

    熟悉相关法规要求和行业标准。例如GMP, 21 CFR部分11/210/211，EU GMP， PDA。 An expert in related regulatory requirements and industry standards, such as GMP, 21 CFR Part 210/211, EU GMP, PDA.Familiar with the requirements of FDA, EU, ISPE/PDA and other regulatory guidelines for qualification and validation. EDUCATION (Indicate the mini. requirement & preferred discipline):

14. 01

    本科或以上学历、药学、生物制药，机械或自动化相关学科 Bachelor's degree or above, pharmacy, biopharmaceuticals, mechanical or automation related disciplines.

15. 02

    有EMA、FDA等审计经验者优先 Priority given to those with audit experience in EMA, FDA, etc. OTHER SKILLS, ABILITIES & EXPERIENCE:

16. 01

    熟悉清洁验证和生物制药生产工艺。 Familiar with cleaning validation and biological production processes.

17. 02

    态度积极，团队合作精神强。 Positive attitude and strong teamwork spirit.