Drug Product Operation / Process Engineer 杭州

月薪：

该公司所有职位
  • 1年经验
  • 本科
  • 招若干人
  • 11-09 发布

职位描述

职位描述： Position responsibility：· Provide local execution support during CTA lot execution at CROs/CMOs. · Execution of DP startup/scaleup/clinical lots production in new facility.· Act as team leader of an operation team of processs technicians.· Author and review documentation such as batch records, procedures, and validation reports.· Support DP supervisor to manage the team through the training, operations, performance etc.· Proactive and Right First Time execute of critical operations.· Process monitoring including real time review of process parameters and process data/trend analysis.· Execution of DP equipment qualification, process and cleaning validation activities.· Cooperation work with related functional departments such as TS, EMU, QA, QC and Supply chain etc.. Especially with EMU to ensure the equipment’s reliability.· Ensure the operation in clean room incl. aseptic area with cGMP and procedures in-house compliance.· Report adverse event RFT and participate to investigations, commitments, and change controls to ensure changes are value added and processes and equipment are robust.· Execute CAPA and continuous improvement. Drive changes that support RFT, efficiency, and/or reduced costs.· Develop programs and strategies for real time process monitoring and RFT.· Provide audit support as SME· Ensure DP operation following QEHS regulations· Provide support to DS operation at startup and when needed.· Execute other items assigned by supervisor.Education and experience qualification:· BS or MS in pharmacy, chemical engineering, biology, biochemistry or other related science or engineering field· Familiarity and experience with solution formulation, aseptic operation, lyphilization· Familiarity and experience with a GMP manufacturing environment desirable.· Previous experience with managing or execution of equipments qualification and process validation desirable.· Previous experience with manufacturing-aseptic operation , autoclave, VHP, isolator and filling line, freeze drying and packaging. is highly desirable.Experience with Six Sigma, Method 1, 5S and/or other operational excellence programs a plus· Enterprise Systems familiarity preferred, namely LabWare LIMS, SAP, TrackWise, PDOCS and EAMS· Previous leadership skills a plus.· Good communication skill in both English and Chinese. 职能类别： 生物工程/生物制药 其他

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公司信息

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，是目前全球最大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“ ”。我们的使命是“ ”。 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.

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