制造工程师

工作目的： 完成制造区域的工作。具备持续改进的意识，以提高个人与团队能力为目标。 Complete work in manufacturing area. Have continuous improvement awareness. Have the goal of improving individual and team capabilities. 具有良好的职业道德、敬业精神及团队协作精神，工作积极主动、责任心强。 Have good professional ethics, professionalism and teamwork spirit, work actively and have a strong sense of responsibility. 主要职责： 1. 一般要求 1）积极参与制造车间的日常工作。 Actively participate in the daily work of manufacturing workshop. 2）按生产计划保质保量完成生产任务；遵循GMP 规范的要求保证产品质量。 Finish the production task according to the production plan to ensure the quality and quantity; Follow GMP specification to ensure product quality. 3）负责制造区域和设备的操作和清洁，确保所用设备保持清洁和完好。 Responsible for the operation and cleaning of the manufacturing equipment to ensure that the equipment is kept clean and in good condition. 4）遵守公司规章制度和GMP要求,并及时报告与GMP相背离的现象。 Comply with company regulations and GMP requirements and report any deviation from GMP. 5）遵循EHS 规范符合环境保护,员工职业保护和生产安全。 In accordance with EHS regulations to comply with environmental protection, employee occupational protection and production safety. 6）按照SOP要求及时准确地填写生产记录。 Fill in the production record timely and accurately according to SOP. 7）提出有建设性的建议并参与提高质量，效率，成本以及安全的项目。 Make constructive suggestions and participate in projects to improve quality, efficiency, cost and safety. 8）具有良好的安全意识和行为，以避免安全事故的发生。 Good safety awareness and behavior to avoid accidents. 9）服从直线经理安排的工作任务，包括培训等。 Obey the task assigned by line manager, including training, etc. 10）当任何违反公司政策、目标或要求的情况发生时要第一时间通知主管。 Inform supervisor immediately of any violation of company policy, objectives and requirements. 2. 主要负责的产品技术工作： 1）负责相关验证工作，包括工艺验证的管理，设备的再确认等 Responsible for relevant validation work, including process validation management, equipment reconfirmation, etc 2）负责设备计算机化系统管理（包括年度回顾、概述、审计追踪、风险评估等） Be responsible for equipment computerized system management (including annual review, overview, audit tracking, risk assessment, etc.) 3）参与相关变更发起、评估、CAPA执行 Participate in relevant change initiation, evaluation and CAPA implementation 4）参与相关偏差的发起、评估、调查、CAPA执行 Participate in the initiation, evaluation, investigation and CAPA implementation of relevant deviations 3. GMP相关工作： 1）负责生产SOP/WI/SPEC的起草和升版 Be responsible for drafting and upgrading sop/wi/spec of the production area 2）负责生产内部偏差、变更、新文件的培训 Be responsible for the training of internal deviations,changes and new documents of the production area 3）负责生产文档的管理，文件分发、回收、归档等 Responsible for production area document management, document distribution, recycling, archiving, etc 4）负责生产设备/设施的计量 Be responsible for the measurement of production area equipment / facilities 4. EHS相关工作： 1）及时发现制造安全隐患并及时上报 Discover and report the potential safety hazards of the manufacturing area in time 2）配合EHS部门完成相关法规检查 Cooperate with EHS department to complete relevant regulatory inspection 3）EHS相关CAPA及时完成并关闭 EHS related CAPA shall be completed and closed in time 学历要求： 本科及以上学历，药学、化学、机电或相关专业。 Bachelor’s degree or above, major in pharmacy, chemistry, mechatronics, or related fields. 工作经验： 制药行业至少1年的工作经历，有项目管理经验，或具备团队带教、协调管理经验者优先。 At least 1 year of work experience in the pharmaceutical industry. Candidates with project management experience or those who have experience in team mentoring, coordination, and management are preferred. 技术技能： • 良好的GMP知识 Good knowledge of GMP • 良好的制药生产知识 Good knowledge of pharmaceutical production • 良好的EHS知识 Good knowledge of EHS • 设备操作动手能力较强 Strong skill of operating equipment • 具有良好的沟通协调能力 Good communication and coordination skills • 具备较强的问题分析与解决能力 Strong problem analysis and problem-solving skills • 具备良好的团队合作意识 Good teamwork spirit 语言和电脑知识： 具有英语听说写能力，英文四级以上 Good command of English in listening, speaking, reading, and writing; CET-4 or above preferred. 较好的数据分析能力，能熟练操作使用包括Excel、Word，PowerPoint等软件的操作。 Strong data analysis skills, proficient in using software such as Excel, Word, and PowerPoint. 百济神州全球胜任力 当我们通过以下十二项全球胜任力，展现出 "患者为先"、"无界协作"、"锐意创新 "和 "追求卓越 "的价值观时，我们就能帮助全世界更多患者获得更多负担得起的药品。 ●团队协作 ●提供并征求坦诚及可行的反馈 ●自我认知 ●兼容并蓄 ●积极主动 ●开拓精神 ●持续学习 ●拥抱变化 ●结果导向 ●分析性思维/数据分析 ●卓越财务 ●清晰沟通 BeOne Global Competencies When we exhibit our values of Patients First, Collaborative Spirit, Bold Ingenuity and Driving Excellence, through our twelve global competencies below, we help get more affordable medicines to more patients around the world. ●Fosters Teamwork ●Provides and Solicits Honest and Actionable Feedback ●Self-Awareness ●Acts Inclusively ●Demonstrates Initiative ●Entrepreneurial Mindset ●Continuous Learning ●Embraces Change ●Results-Oriented ●Analytical Thinking/Data Analysis ●Financial Excellence ●Communicates with Clarity 求职者隐私申明： 百济神州致力于尊重和保护您的个人信息权利，并承诺依据合法、正当、必要和诚信的原则处理您的个人信息（包括个人敏感信息 ）。 由于百济神州在全球范围内开展业务，我们可能需要基于人力资源管理等合理业务目的而将您的个人信息发送和/或存储在位于您所在国家以外其他国家（例如：美国）的服务器和数据库中，详情参见百济神州《求职者隐私政策》（百济神州官网 - 隐私政策 - 求职者隐私政策）。 如您主动向我们提供您的简历信息或其他个人信息，则视为您已经充分理解并确认接受百济神州《求职者隐私政策》内容。如您对此有任何疑问的，请勿提交简历信息或其他个人信息。 BeOne is committed to respect and protect your personal information rights, and will process your personal information, including your sensitive personal information, based on the principles of legality, legitimacy, necessity, and integrity. 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