东莞招聘

工作职责:

参与原液生产操作。执行生产、确认和验证工作，包括产品生产操作、车间清洁和产品切换清洁、设备操作、溶液配制、生产批记录审核和特殊样品协调。对问题解决、技术转移和投产准备提供支持。协助主管执行偏差调查、工艺数据分析和工艺过程改进工作。对工艺实验设计提供生产支持，如混合系统、产品转移和其他相关生物过程控制系统等。能够制备并介绍技术分享资料。了解cGMP需求和安全操作要求，并且针对内部和外部审计提供审计支持。

Participate in the execution of pharmaceutical manufacturing processes. Execute manufacturing and qualification/validation activity, including product operations, suite clearance and changeover, equipment processing, solution formulation, manufacturing batch record review and special sample coordination. Provide support in troubleshooting activities, technology transfer and start-up activities. Support superviser to execute investigations, analyze process data and identify and implement process improvements. Provide support of process of experimental design with regard to system mixing, mass transfer, and other pertinent aspects of bioprocess system control. Author and present comprehensive technical presentations and procedures. Thorough understanding of cGMP requirements and safety practices and provide audit support to several internal and external audits.

针对在CRO生产的CTA批次提供支持。Provide local execution support during CTA lot execution at CROs.

按照SOP要求在新建生产车间进行原液生产前准备，工艺放大及临床批次生产。Perform standard operating procedures of DS startup/scaleup/clinical lots production in new facility.

在主管的指导下编写相关文件，如生产批记录，SOP和验证报告等。Author documentation such as batch records, procedures, and validation reports as directed by supervisor.

对关键操作提供实时一次正确率支持。Provide real-time RFT support of critical operations.

与主管一起沟通解决生产操作中的不一致行为。Work with supervisor to communicate and resolve operational variances.

负责工艺监控，包括工艺参数和工艺数据/趋势分析的实时回顾。Process monitoring including real time review of process parameters and process data/trend analysis.

负责部门间和班组间的信息沟通。Communicate process performance across shifts and departments.

协助主管进行工艺改进，设备能力评估和新技术的使用。Support supervisor to Implement process enhancements, measure and respond to equipment capability and implement new technologies.

保证操作符合质量安全规章。Execute operation following QEHS regulations.

参与调查和变更控制，确保变更具有附加价值并且变更后工艺和设备稳定。Participate investigations, and change controls to ensure changes are value added and processes and equipment are robust.

参与创新文化和持续改进。 主动领导变更能够提高一次正确率，生产效率和成本减少。Participate a culture of Innovation and Continuous improvement. Drive changes that support Right First Time, Efficiency, and/or reduced costs.

提供审计支持。Provide Audit support 。

执行主管分配的其他工作。Execute other items assigned by supervisor.

根据生产需要进行倒班生产。

Attend shift work according to manufacturing requirement.

任职资格:

教育程度/经验 Education/Experiences

？ 本科及以上药学、化工、生物、生物化学及其他相关专业。

BS or MS in chemical engineering, biology, biochemistry or other related science or engineering field.

？ 有相关工作经验。

Experience working in related environment is a plus.

特别知识/技能 Specific Knowledge & Skills

？ 良好的英语口语和写作能力

Good English oral and written communication skills are required.

？ 熟悉蛋白质纯化工艺及溶液配制者优先

Familiarity with protein purification process. Solution formulation is not essential, but is highly desirable.

？ 熟悉GMP生产为加分项。

Familiarity and experience with a GMP manufacturing environment is a plus.

？ 熟悉工业规模层析系统及超滤洗滤系统为加分项

Familiarity with manufacturing-scale column chromatography and/or tangential flow filtration (UF/DF) a plus

？ 有6西格玛及5s管理经验者优先

Experience with Six Sigma, Method 1, 5S and/or other operational excellence programs a plus

辉瑞公司（Pfizer Inc.）创建于1849年，迄今已有160多年的历史，总部位于美国纽约，是目前全球***的以研发为基础的生物制药公司。辉瑞致力于运用创新的科学技术以及全球资源来改善每个生命阶段的健康和福祉。
我们的目标是“不断创新为患者带来能显著改善其健康的药物”。我们的使命是“成为一家卓越的创新型生物制药公司”。
2012年辉瑞公司全年合计收入590亿美元，研发投入78亿美元。辉瑞在全球拥有9万多名员工，59家生产基地，业务遍及全球150多个国家和地区。2012年财富全球500强企业中辉瑞排名126位。
目前辉瑞公司的产品覆盖了包括化学药物、生物制剂、疫苗、健康药物、动物保健品等用于人类、动物和消费者保健等诸多广泛而极具潜力的治疗及健康领域，同时其卓越的研发和生产能力处于全球领先地位。
在人类和动物药品的发现、开发和生产过程中，辉瑞始终致力于奉行严格的质量、安全和价值标准。每天，分布在世界各地的辉瑞员工致力于促进当地医疗卫生的发展以及探索能够应对当今最为棘手疾病的预防和治疗方案。
辉瑞还与世界各地的医疗卫生专业人士、政府和社区合作，支持世界各地的人们能够获得更为可靠和可承付的医疗卫生服务。这与辉瑞作为一家世界领先的生物制药公司的责任是一致的。160多年来，辉瑞一直努力为人们提供更好、更优质的服务。
辉瑞生物制药目前在华上市的创新药物已超过50个，其治疗领域涵盖了心脑血管及代谢、抗感染、中枢神经、抗炎镇痛、抗肿瘤、泌尿、疫苗及等诸多领域。其中如立普妥®、络活喜®、万艾可®、舒普深®、希舒美®、沛儿®、索坦®许多产品在市场上处于领先地位。为了让中国的广大患者能及时接受与全球同步的先进的药物治疗，辉瑞未来将进一步加大和加快在华新药引进和上市的力度和速度。
辉瑞健康药物旗下的善存®、钙尔奇®、惠菲宁®等消费保健产品也在中国市场家喻户晓，并以其优异的品质深受广大消费者的青睐；辉瑞旗下的硕腾动物保健品*为中国的动物保健市场提供各类领先的动物疫苗和动物药品。

At Pfizer, we apply science and our global resources to improve health and well-being at every stage of life. We strive to set the standard for quality, safety and value in the discovery, development and manufacturing of medicines for people and animals. Our diversified global health care portfolio includes human and animal biologic and small molecule medicines and vaccines, as well as nutritional products of healthcare industry and many of the world's best-known healthcare products such as Centrum. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as the world's leading biopharmaceutical company, we also collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 160 years, Pfizer has worked to make a difference for all who rely on us.