Job Responsibility 岗位职责： 1. Document Control 文档管理 Assist in drafting, reviewing, and organizing technical documents, SOPs (Standard Operating Procedures), and validation reports to ensure proper documentation and compliance with internal and external requirements. 协助团队起草、审核和整理技术文档、标准操作规程（SOP）和验证报告，确保文档合规性并满足内部和外部要求。 2. Support Calibration Activities 支持校准活动 Learn and assist in calibration checks for critical equipment and instruments to ensure they meet accuracy and functionality standards. 学习并协助完成对关键设备和仪器的校准工作，确保设备符合准确性要求并功能正常。 3. Validation Support 验证支持 Assist in validation activities such as equipment validation, cleaning validation, transportation validation, and temperature-controlled validation to ensure compliance with regulatory and GMP requirements. 协助完成设备验证、清洁验证、运输验证和温控验证等验证工作，确保符合法规和GMP要求。 4. Continuous Improvement Projects 持续改进项目 Support small-scale Kaizen or optimization initiatives to improve existing processes, equipment performance, and operational efficiency. 协助团队完成小型Kaizen或优化项目，提高现有流程、设备性能与运营效率。 5. Data Collection and Analysis 数据收集与分析 Assist in collecting and analyzing equipment performance, maintenance trends, or validation data, generating reports for decision-making as needed. 协助收集与设备性能、维护趋势或验证相关的数据，并完成分析及报告整理，为决策提供支持。 6. Basic Troubleshooting 基础故障排查 Under guidance, support simple troubleshooting for equipment and systems, learning problem-solving methods and routines. 在指导下参与简单的设备与系统问题排查，学习解决问题的基本方法与流程。 7. Equipment Life Cycle Management 设备生命周期管理 Gain an understanding of equipment lifecycle processes, including installation, qualification, preventive maintenance, and retirement plans. 学习了解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。 8. Exposure to Industry Best Practices 行业最佳实践学习 Study and apply industry best practices from ISPE guidelines, PDA technical reports, and regulatory requirements to enhance operational strategies. 学习并尝试将ISPE指南、PDA行业技术报告及法规要求应用到日常工作中，提升运维策略的合理性。 9. Support Production Operations 支持生产运行 Provide basic support for production operations, such as assisting in equipment troubleshooting, maintenance, and implementing equipment availability improvements (e.g., preventive maintenance). 为生产运行提供基础支持，包括协助设备故障排查、维护及推动设备运行效率的提升（如预防性维护）。 10. Cross-Functional Communication 跨部门沟通 Assist in communicating with cross-functional teams (e.g., process, quality, and compliance), participate in documentation for change control (ECR/ECN), and support deviation and CAPA handling. 协助跨部门沟通（如工艺、质量、合规部门），协助完成变更控制（ECR/ECN）文档处理及偏差/CAPA支持。 11. Promote Equipment Improvements 推进设备改进 Under supervision, assist in promoting equipment reliability improvements, energy efficiency projects, or basic automation upgrades (e.g., PLC/SCADA). 在指导下协助推进设备可靠性改进、能效优化或工艺自动化（如PLC/SCADA）升级的基础工作。 ________________________________________ Job Requirements 任职要求： 1. Educational Background 教育背景 Bachelor's degree or higher in Mechanical Engineering, Automation, Pharmaceutical Engineering, Bioengineering, HVAC, Environmental Engineering, or a related field. 本科及以上学历，专业为机械工程、自动化、制药工程、生物工程、暖通或环境工程等相关领域。 2. English Proficiency 英语能力 Basic English listening, speaking, reading, and writing skills; ability to read and translate simple English regulatory or technical documents is a plus. 具备基本的英文听说读写能力，能够阅读和翻译简单的英文法规文件及技术资料者优先。 3. Collaboration Skills 协作能力 Basic communication, problem-solving, and teamwork skills; willingness to develop cross-departmental coordination and project management abilities. 具备良好的沟通能力及团队协作能力，有意愿在跨部门协调及项目管理中获得提升。 4. Detail-Oriented and Proactive 细致与积极性 Detail-oriented, responsible, and proactive; able to adapt to moderate work pressure in a supportive environment. 工作认真细致，责任心强，主动性高，能适应适度工作压力，有意愿在支持性环境中学习成长。 5. Microsoft Office Proficiency 熟悉办公软件 Proficient in or familiar with Microsoft Office tools (e.g., Word, Excel, PowerPoint). 熟悉或能熟练使用Office办公软件（如Word、Excel、PPT等）。