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Site Engineering and Validation Intern-SZ

苏州
生物工程类·药学类
使用简历深度优化功能,快速提升简历质量
职位介绍
招聘部门:工程及验证部 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 suppor
所属批次:无锡药明生物技术股份有限公司 2026届校园招聘简章企业职位库在招档案