信息技术工程师 - 生产制造

Job Summary职位概述:
As a senior member of the Roche Diagnostics Manufacturing IT team, you will support the IT Manager in maintaining the complete life cycle of the applications for the Suzhou site. You will ensure GxP-compliant operations, guarantee system availability, and take ownership of managing serialization systems. Furthermore, you are expected to independently lead and execute Computer System Validation (CSV) activities. You will work efficiently with internal teams and external service providers to deliver robust IT solutions aligned with site manufacturing business processes. 作为设备制造 IT 团队的高级成员，您将协助信息技术经理支持苏州工厂应用程序的整个生命周期。确保符合 GxP 标准的运行，保证系统可用性，并负责序列化系统的管理。此外，期望您能独立领导并执行计算机系统验证（CSV）活动。您将与内部团队及外部服务提供商高效合作，提供与现场制造业务流程相匹配的可靠 IT 解决方案。
Main Tasks & Responsibilities主要工作职责 :
Manage and support the complete life cycle of Serialization Systems (Track & Trace) supporting packaging and manufacturing processes. 管理并支持用于包装和生产流程的序列化系统 (追踪与追溯) 的完整生命周期。
Independently plan, execute, and complete Computer System Validation (CSV) and equipment qualification activities according to internal Roche requirements and GxP standards. 根据罗氏内部要求和 GxP 标准，独立规划、执行并完成计算机系统验证 (CSV) 和设备确认活动。
Responsibility for the complete life cycle of other IT applications supporting Suzhou manufacturing including packaging, warehouse, quality control, etc. 负责苏州工厂支持生产的其他 IT 系统（包括包装、仓库、质量控制等）的完整生命周期。
Lead the implementation, installation, and testing of highly complex IT systems under GxP conditions. 领导在 GxP 条件下高复杂性 IT 系统的实施、安装和测试。
Analysis, elimination, and documentation of events (incidents, problems, and changes). 分析、解决和记录事件（事件、问题和变更）。
Act as a business partner from IT to understand complex business requirements and convert them into proper IT solutions or services. 作为IT部门的业务合作伙伴，理解复杂的业务需求并将其转化为合适的 IT 解决方案或服务。
Maintain adequate documentation in accordance with relevant documentation standards. 根据相关文档标准维护充分的文档。