药明生物

Job Responsibility 岗位职责： 1. 设备生命周期管理 Equipment Life Cycle Management 负责设备的全生命周期管理，包括安装、确认、预防性维护与设备退役计划。 Responsible for full lifecycle management of equipment, including installation, qualification, preventive maintenance, and retirement strategies. 2.生物制药厂房设计 Facility Design for Biopharmaceuticals 参与设计生物制药厂房，确保符合GMP标准和相关法规要求。 Participate in the design of biopharmaceutical facilities to ensure compliance with GMP standards and relevant regulations. 支持厂房建设项目的施工过程与新设施试运行活动，确保达到验证要求并满足生产需求。 Support construction projects and commissioning activities for new facilities to meet qualification requirements and production needs. 3. 验证管理 Validation Management 负责验证体系的建设与持续优化，包括验证/确认计划的编写，相关SOP及风险评估的制定与更新。 Lead the development and optimization of validation systems, including drafting validation/qualification plans, writing and updating related SOPs, and conducting risk assessments. 起草并执行清洁验证、运输验证、温控验证计划和相关文件（风险评估、方案及总结报告）；参与厂房、设备、工艺等验证的策划和实施工作，确保符合法规、GMP及质量管理体系（QMS）的要求。 Draft and execute cleaning, transportation, and temperature control validation plans and associated documentation (risk assessments, protocols, and summary reports). Participate in facility, equipment, and process validation to ensure compliance with regulatory requirements, GMP, and quality management systems (QMS). 负责再确认/再验证活动，维持设备及工艺的验证状态；应对内外部审计，参与验证偏差调查以及CAPA实施。 Perform requalification/revalidation activities to maintain validated status. Respond to internal and external audits, investigate validation deviations, and execute CAPA activities. 4. 生产工艺设备管理 Process Equipment Management 参与生物制药工艺设备的选型及技术评估，确保设备性能符合工艺要求并满足行业监管标准。 Assist in the selection and technical evaluation of biopharmaceutical process equipment to ensure process compatibility and compliance with regulatory standards. 配合工艺部门开展工艺优化项目，参与设备参数调试与性能测试，提升生产效率与产品质量一致性。 Collaborate with process teams on optimization projects, participating in equipment parameter adjustments and performance testing to enhance productivity and product quality consistency. 制定并优化各类生产设备的预防性维护计划、校准计划及标准操作规程（SOP），参与巡检与维护工作，降低设备故障率，保障生产连续稳定运行。 Develop and optimize preventive maintenance plans, calibration schedules, and SOPs for production equipment. Support inspections and maintenance to minimize failures and ensure uninterrupted production. 5. 自动化设备管理 Automation Management 支持自动化系统（如SCADA、PLC以及MES系统）的运维、优化与升级，确保其准确高效运行，符合相关法规要求。 Manage and optimize automated systems (e.g., SCADA, PLC, MES) to ensure their accurate and efficient operation, in compliance with regulatory requirements. 协助进行自动化系统的故障排查及问题诊断，参与相关问题的根因分析与解决方案的实施。 Assist in troubleshooting and diagnosing issues in automated systems, supporting root cause analysis and implementation of solutions 6. 公用设施管理 Facility & Utility Management 支持新设施的设计、调试与确认活动（C&Q），确保其符合cGMP及国家法规要求，并协助制订设施扩建的战略规划。 Support the design, commissioning and qualification (C&Q) of new facilities to meet cGMP and regulatory requirements, assisting in strategic planning for facility expansion. 负责厂区内GMP及非GMP设施、公用设施的运维与改造工作，包括日常运行、校准、维护及系统优化。 Manage utilities related to both GMP and non-GMP facilities, including operations, calibration, maintenance, and modifications. 7. 计量管理 Metrology Management 负责关键设备和检测仪器的校准计划编制、执行及记录管理；协调校准供应商，确保仪器设备的准确性与合规性。 Develop, execute, and manage calibration schedules for critical equipment and instruments. Liaise with calibration vendors to ensure compliance and accuracy of instruments. 收集与分析校准数据，监控校准趋势，并提出优化改进建议，为相关决策提供支持。 Collect and analyze calibration data, monitor trends, and recommend enhancements to support decision-making. 8. 备件管理 Spare Parts Management 负责设备备件的科学管理，制定并优化备件清单和库存策略，确保关键设备备件的可用性，同时控制备件成本。 Manage spare parts scientifically by establishing spare part lists and inventory strategies, ensuring critical equipment availability while controlling costs. 9. 数据管理与分析 Data Management & Analysis 协助收集与设备性能、维护趋势或验证相关的数据，并完成相关分析及报告整理，为决策提供数据支持。 Assist in collecting, analyzing, and reporting data related to equipment performance, maintenance trends, or validation activities to support decision-making. 10. 审计支持：Audit Support: · 参与并支持由药监机构（如FDA、EMA、NMPA）进行的审计工作，确保设备符合国际GMP标准及相关法规要求。负责准备多语言审计材料、回答审计机构提出的问题、并协助改善发现项。积极跟踪全球法规动态，与内外部团队协作调整策略，从而保证合规性和持续改进。 Participate and support audits conducted by regulatory agencies such as FDA, EMA, and NMPA, ensuring equipment meets international GMP standards and relevant regulatory requirements. Responsible for preparing multilingual audit materials, addressing questions raised by regulatory agencies, and assisting in improving audit findings. Actively track global regulatory updates and collaborate with internal and external teams to adjust strategies, ensuring compliance and continuous improvement. 11. 跨部门协调和支持 Cross-functional Coordination & Support 协助生产、质量（QA）、合规（EHS）、采购等部门，解决设备运维、验证及生产优化方面的跨部门事务，支持日常运营和项目推进。 Act as a hub to coordinate Production, Quality (QA), Compliance (EHS), Procurement, and other departments to support equipment maintenance, validation, and continuous improvement projects. 支持内部审核与外部审计，协助处理偏差、CAPA等活动，推动流程改进，提高运行效率。 Support internal and external audits, assist with deviation investigations, and CAPA implementation, and drive process optimization to enhance operational efficiency. 12. 国际学习与实践机会：International Learning and Practice Opportunities: · 公司为表现卓越的员工提供海外学习和培训的机会，如在美国、新加坡的相关团队进行实地学习与交流。员工将有机会深入了解国际行业最佳实践、法规标准，并将其应用于现有工作中，为个人发展和组织提升带来助力。同时，这一机会将帮助员工提升跨文化沟通能力与专业技术水平。 The company offers outstanding employee’s opportunities for overseas learning and training, such as on-site learning and communication within related teams located in the United States or Singapore. Employees will gain valuable insights into international industry with the best practices and regulatory standards, applying them to their current work to enhance individual development and organizational performance. This opportunity also aims to help employees improve cross-cultural communication skills and professional expertise. Job Requirements 任职要求： 1. 教育背景 Educational Background 本科或硕士学历，自动化、制药工程、生物工程、机械工程、暖通工程或环境工程等相关领域。 Bachelor’s or master’s degree in mechanical engineering, Automation, Pharmaceutical Engineering, Bioengineering, HVAC Engineering, Environmental Engineering, or a related field. 2. 英语能力 English Proficiency 熟练掌握英语的听、说、读、写能力，能够阅读并翻译中英文法规文件及技术资料。 Proficient in English listening, speaking, reading, and writing, with the ability to read and translate English regulatory and technical documents. 3. 专业技能 Professional Skills 具备良好的问题解决能力，熟悉基本的故障排查和根因分析方法。 Strong problem-solving skills, familiar with basic troubleshooting and root cause analysis methods. 4. 综合素质 General Competencies 工作细致、责任心强、主动性高，能够适应适度的工作压力。 Attention to detail, strong sense of responsibility, proactive attitude, and adaptability with moderate work pressure. 具备优秀的团队协作与跨部门沟通能力，愿意在支持性环境中学习和成长。 Excellent teamwork and cross-functional communication skills, with a willingness to learn and grow in a supportive environment. 关于我们About Us： 药明生物（股票代码：2269.HK）是一家全球领先的合同研究、开发和生产（CRDMO）公司。公司通过开放式、一体化生物制药能力和技术赋能平台，提供全方位的端到端服务，帮助合作伙伴发现、开发及生产生物药，实现从概念到商业化生产的全过程，加速全球生物药研发进程，降低研发成本，造福病患。 药明生物在中国、美国、爱尔兰、德国、新加坡和卡塔尔拥有超过12000名员工。通过药明生物的专业服务团队，以及先进技术和精深洞见，公司为客户提供高效经济的生物药解决方案。截至2025年12月底，药明生物帮助客户研发和生产的综合项目高达945个，其中包括74个临床III期项目，25个商业化生产项目。 药明生物将环境、社会和治理（ESG）视为业务发展和企业精神的重要组成部分，并致力于成为全球生物药CRDMO领域的ESG领导者，例如应用更绿色环保的新一代生物制药技术和能源等引领行业发展。公司成立了由首席执行官领导的ESG委员会，全面落实ESG战略并践行可持续性发展承诺。 WuXi Biologics (stock code: 2269.HK) is a leading global Contract Research, Development and Manufacturing Organization (CRDMO) offering end-to-end solutions that enable partners to discover, develop and manufacture biologics – from concept to commercialization – for the benefit of patients worldwide. With over 12,000 skilled employees in China, the United States, Ireland, Germany, Singapore and Qatar, WuXi Biologics leverages its technologies and expertise to provide customers with efficient and cost-effective biologics discovery, development and manufacturing solutions. As of December 31, 2025, WuXi Biologics is supporting 945 integrated client projects, including 74 in Phase III and 25 in commercial manufacturing. WuXi Biologics views Environmental, Social, and Governance (ESG) responsibilities as an integral component of our ethos and business strategy, and we aim to become an ESG leader in the biologics CRDMO sector. Our facilities use next-generation biomanufacturing technologies and clean-energy sources. We have also established an ESG committee led by our CEO to steer the comprehensive ESG strategy and its implementation, enhancing our commitment to sustainability. 申请职位 允许6个月内投递3个职位，请选择适合的职位进行投递