南京招聘

Expected Areas of Responsibilities
工作职责

1. Responsibilities of Process Engineer
工艺工程师职责
1.1 To support world-class manufacturing with robust, cost-effective and manufacturable designs for both product and raw material. Lead technical elements of closed-loop corrective action and problem-solving within SASS plant and at suppliers. Solve manufacturing problems of related products in production. Initiate and implement productivity improvement projects. 以世界领先的标准支持生产活动，以期达到低成本、稳健生产和可持续生产产品和原料的目标对供应商及本厂区的问题进行彻底的技术整改和解决解决相关产品生产过程中出现的技术问题，提高劳动生产率
1.1.1 Solve all kinds of problems in routine commercial production. Find the root cause from the technical process aspect. Find ways to solve the problems with other related departments. Implement the measures in routine production and follow up the results. 解决日常生产过程中产品出现的各种问题，从工艺的角度寻找问题产生的根本原因，和其它相关部门一起找到解决问题的方法，并在实际生产中实施，同时跟踪问题解决的效果
1.1.2 Improve the manufacturing process continuously in order to improve the productivity. Improve the process of related commercial products including weighing, granulation, final mixing, tablet compression, coating, packaging, etc. Improve the productivity, save the labor hours, reduce the circle time and decrease the strength of the labor. 持续改进生产工艺，提高生产效率对现有的相关产品通过对称量、制粒、总混、压片、包衣和包装等各个工序的生产工艺进行改进，提高生产效率，节约劳动工时，减少生产周期，降低劳动强度

2. Responsibilities of Validation Engineer
验证工程师职责
2.1 Generate the qualification protocol and circulate for approval including (but not limited to) process & product, system validation, cleaning validation, method validation and equipment performance qualification, etc.
建立认证的方案并流转批准，包括（但不限于）产品和工艺验证、系统验证、清洁验证、方法验证、设备运行验证等
2.1.1 Conduct qualification trials.
指导认证试验
2.1.2 Investigate and document any out of tolerance conditions.
调查异常情况
2.1.3 Accumulate, compile and evaluate all test results.
积累，评估测试结果
2.1.4 Prepare the qualification report and circulate for approval.
准备验证报告和流转签字
2.2 Compliance
合规
2.2.1 Ensure validation related activities and documentation are in compliance with regulatory, quality and safety
guidelines
确保验证相关活动和文件符合质量和安全指南的要求
2.3 For any process & system that have been validated after three years, assessment study will be carried out according to the Validation Guideline issued by BMS Headquarters. Confirmation validation will be performed if determined to be necessary after document review.
对于公司已有的任何产品工艺和系统，且已做过验证后三年，根据BMS总部发布的验证指南要求进行评估研究在审阅后，如有必要将进行确认验证
3. New Product Development Responsibilities/新产品开发职责
3.1 Coordinate Worldwide Technical for any technical initiatives and implementation of the initiatives in the plant and technical transfer for specific new product/project.
确保全球制药总部发起的特定的新产品/新项目在本工厂的实施和技术转移
3.1.1 Make preparation for trials and launch production of new product/project in SASS. Coordinate with relevant departments to arrange the trials and launch production of new product/project. Ensure the new product/project manufactured by SASS comply with the requirements for new drug registration and GMP regulations. 根据计划准备新产品/新项目在SASS的试制和生产方案，多方协调和组织新产品/新项目的试制和生产，确保质量达到新药注册标 准和GMP的要求
3.1.2 Solve the process and technical problems during new product/project trials and launch production.
及时解决新产品/新项目试制和生产过程中出现的工艺和技术问题
3.1.3 Determine the optimum formula, process and parameters by small-scale trials before the formal new product/project trials and production if necessary.
如有必要，在正式的新产品/新项目试制和生产前进行小试，以确定最佳的工艺和参数


Experiences Desired
相关工作经验要求
1. 5 years or above relevant working experience in a Multi-national pharmaceutical industry
5年以上跨国医药企业相关工作背景
2. Experience in product/process validation, site service and new product development.
在产品工艺验证、生产现场服务和新产品开发方面有丰富的知识与经验
3. Bachelor degree or above, major in Pharmaceutical or related subject
本科学历或以上，主修制药或相关专业
4. Have an excellent ability to listen, speak, read and write in both English and Chinese
具有良好的中英文听说读写能力
5. Ability to use MS Office
具备使用办公室软件的能力
6. Ability of proactive in problem finding and solving problems, good team work and ability to communicate
具备发现问题、解决问题，良好的团队合作精神及沟通的能力
7. Ability of positive, proactive, always look for opportunities and challenge
具备积极主动、总能寻找机会和挑战的能力

百时美施贵宝是一家以“研发并提供创新药物，帮助患者战胜严重疾病”为使命的全球性生物制药公司。

2019年11月20日，百时美施贵宝成功完成了对新基的收购，将双方在领先的科学、创新的药物和优秀的人才等方面的优势合二为一，打造全球领先的生物制药企业。公司在肿瘤、血液、免疫和心血管疾病等领域处于世界前列，并具有丰富的，且具有行业前景的产品管线。

如今，中国已是百时美施贵宝公司全球重要的研发、生产、营销和创新中心之一。我们致力于满足中国未被满足的迫切的重大疾病需求，引领行业发展，开展多元合作，以帮助中国患者战胜严重疾病。