GMP Senior/Principal IT Engineer(Shanghai)

I. Position SummaryThis role is responsible for the full lifecycle management of the company's global GMP-related IT systems supporting QC. Acting as the technical bridge between IT and QC, the role ensures system stability and compliance within a local data center and private cloud environment. The engineer must balance GMP compliance requirements with global multi-timezone business continuity, and possess code-level troubleshooting capabilities as well as experience with digital productivity tools.II. Core Responsibilities1. GMP IT System Lifecycle Management·Act as the IT Owner or key technical lead for systems supporting QC.·Responsible for system high-level design, technology selection, version upgrades, and retirement management.·Establish and maintain the compliance baseline for system operations (including configuration, access control, audit trail, time synchronization, backup and recovery).·Participate in IT technical investigations of system-related deviations or changes, providing technical root cause analysis and corrective action plans.2. In-Depth Troubleshooting of System and Interface Failures·Possess coding capability to deeply investigate system failures (e.g., service crashes, performance degradation, data inconsistencies).·Troubleshoot interface failures (e.g., between LIMS and LES), including:oAnalyzing interface logs, error stacks, and data payloads.oIdentifying whether the issue resides in a specific system, service, or code logic.oDistinguishing between configuration issues, data problems, network faults, or code defects.·Write or modify small scripts/tools for failure reproduction, log analysis, data validation, or automated remediation.3. Application of Digital Productivity Tools·Identify opportunities for digital efficiency improvements within GMP business processes (e.g., approval workflow automation, automated report generation, data reconciliation).·Utilize tools such as Power Automate, RPA, and low-code platforms to achieve process automation within a compliant framework.·Possess a basic understanding of AI/machine learning application scenarios in GMP environments (e.g., audit trail anomaly detection, predictive maintenance).4. Multi-Timezone Global Operations and Emergency Response·Support operations across multiple time zones (e.g., Europe, China, United States).·Balance business recovery and compliance records during emergency situations.·Manage change control windows, patching cycles, and system maintenance plans across time zones.5. IT Architecture and Infrastructure·Participate in the design of IT architecture for GMP systems (servers, VMware virtualization, storage, network segmentation, firewall policies).·Manage system deployment, data synchronization, and disaster recovery strategies between the local data center and private cloud platforms.·Identify and mitigate GMP risks at the IT infrastructure level.6. CSV/CSA and Regulatory Compliance·Lead or participate in computerized system validation activities (risk assessment, validation strategy, documentation review).·Ensure systems comply with EU GMP Annex 11, 21 CFR Part 11, data integrity (ALCOA+), and NMPA requirements.·Support global regulatory inspections (FDA, EMA, NMPA, etc.), handling IT-related audit support and CAPA execution.7. Cross-Functional and Vendor Collaboration·Serve as the technical interface between IT and QC.·Manage global system vendors and integrators, driving them to resolve interface and system defects.III. QualificationsEducation·Bachelor's degree or higher in Computer Science, Information Systems, Software Engineering, Automation, Data Science, or a related field.Work Experience·5+ years of IT-related experience, with at least 3 years in a GMP/GxP environment.·Experience in pharmaceutical, biopharmaceutical or vaccine industries is preferred.·Experience supporting global multi-site or multi-time zone operations is preferred.·Experience in LIMS or ELN is preferred.Required SkillsCode and Troubleshooting Ability·Proficient in at least one programming/scripting language (e.g., Python, PowerShell, C#, Java, JavaScript), with the ability to:oRead and understand existing code/script logic.oWrite small tools for log analysis, data validation, interface testing, and automated remediation.oIdentify code-level root causes for system and interface failures.·Familiar with common interface protocols (RESTful API, SOAP, message queues, direct database connections, etc.).·Able to analyze interface logs, error stacks, and network packet captures to determine issue ownership.Digital Productivity Tool Experience·Hands-on experience with Power Automate, RPA (e.g., UiPath), low-code platforms, etc.·Capable of designing and deploying automated processes within GMP compliance constraints.·Basic understanding of AI/LLM applications in GMP scenarios.GMP and Compliance·Deep understanding of how GMP regulations apply to IT systems.·Familiar with computerized system validation (CSV or CSA).·Mastery of key data integrity control points (audit trail, access control, time synchronization, backup/restore).IT Technical Capabilities·Windows/Linux Server administration.·Virtualization platforms.·Databases (SQL Server/Oracle), with ability to write complex queries, analyze execution plans, and identify performance bottlenecks.·Networking fundamentals (VLAN, firewall, NTP, DNS).·Storage and backup principles.Risk Judgment·Able to independently assess the GMP impact level of an IT action (e.g., service restart, configuration change, temporary workaround).·Capable of making decisions that are "operationally recoverable and compliantly explainable" under emergency situations.Soft Skills·Strong sense of responsibility and respect for compliance.·Ability to explain technical issues to business in non-IT language.·Cross-time-zone collaboration capability (written English plus verbal communication).·Solves problems systematically rather than applying superficial fixes.AI-Related Experience·Understanding or hands-on experience with AI application scenarios in GMP environments (e.g., audit trail anomaly detection, predictive maintenance, LLM-assisted documentation processing).·Experience collaborating with data science teams to deploy AI models in regulated environments.IV. Nice-to-Have·Experience as a System Owner, or participation in official FDA/EMA/NMPA inspections with on-site response.·Experience deploying or operating GMP systems in a hybrid cloud environment.·Familiarity with ITIL (Incident, Change, Problem, Configuration Management).一、岗位概述负责公司全球GMP相关支持QC业务的IT系统的全生命周期管理。作为IT与QC之间的技术桥梁，在本地数据中心+私有云环境下，确保系统稳定、合规。需平衡GMP合规要求与全球多时区业务连续性，具备代码级故障定位能力和数字化工具应用经验。二、核心职责1. GMP IT系统全生命周期管理·作为QC系统的IT Owner或核心技术负责人·负责系统的顶层设计、技术选型、版本升级、退役管理·制定并维护系统合规运行基准（含配置、权限、审计追踪、时间同步、备份恢复）·参与系统相关偏差/变更的IT技术调查，输出技术根因与整改方案2. 系统故障与接口故障的深度排查·具备代码能力，能够深入排查系统故障（如服务崩溃、性能恶化、数据不一致）·能够排查接口故障（如LIMS ↔ LES），包括：o分析接口日志、错误堆栈、数据报文o定位问题在哪个系统、哪个服务、哪段代码逻辑o区分是配置问题、数据问题、网络问题还是代码缺陷·编写或修改小脚本/工具用于故障复现、日志分析、数据校验或自动化修复3. 数字化工具应用·识别GMP业务流程中的数字化提效机会（如审批流自动化、报告自动生成、数据核对）·运用Power Automate、RPA、低代码平台等工具，在合规框架下实现流程自动化·对AI/机器学习在GMP环境中的应用场景有基本认知（如审计追踪异常检测、预测性维护等）4. 多时区全球运维与应急响应·支持跨时区（如欧洲、中国、美国）的支持·在紧急情况下平衡业务恢复与合规记录·管理跨时区的变更窗口、补丁周期及系统维护计划5. IT架构与基础设施·参与设计GMP系统的IT架构（服务器、虚拟化VMware、存储、网络分段、防火墙策略）·管理本地数据中心与私有云平台之间的系统部署、数据同步与灾备策略·识别并降低IT基础设施层面的GMP风险6. CSV/CSA与法规合规·主导或参与计算机化系统验证活动（风险评估、验证策略、文档审核）·确保系统符合EU GMP Annex 11、21 CFR Part 11、数据完整性（ALCOA+）、NMPA要求·支持全球监管检查（FDA、EMA、NMPA等），负责IT相关迎审与CAPA执行7. 跨部门与供应商协作·作为IT与QC的技术接口·管理全球系统供应商、集成商，推动其解决接口及系统缺陷三、任职资格教育背景·本科及以上学历，计算机、信息系统、软件工程、自动化、数据科学等相关专业工作经验·5年以上IT相关经验，其中至少3年GMP/GxP环境下的IT系统经验·有制药、生物制药或疫苗行业经验者优先·有全球多站点或多时区支持经验者优先·有LIMS或ELN系统经验优先必备技能代码与故障定位能力·掌握至少一种编程/脚本语言（如Python、PowerShell、C#、Java、JavaScript），能够：o阅读和理解现有代码/脚本逻辑o编写小工具用于日志分析、数据校验、接口测试、自动化修复o定位系统故障和接口故障的代码级根因·熟悉常见接口协议（RESTful API、SOAP、消息队列、数据库直连等）·能够分析接口日志、错误堆栈、网络抓包，区分问题归属数字化工具经验·有Power Automate、RPA、低代码平台等实际使用经验·能够在GMP合规约束下设计和部署自动化流程·对AI/LLM在GMP场景的应用有基本认知GMP与合规·深刻理解GMP法规在IT系统中的落地要求·熟悉计算机化系统验证（CSV或CSA）·掌握数据完整性核心控制点（审计追踪、权限、时间同步、备份还原）IT技术能力·Windows/Linux Server管理·虚拟化平台·数据库（SQL Server/Oracle），能编写复杂查询、分析执行计划、定位性能瓶颈·网络基础（VLAN、防火墙、NTP、DNS）·存储与备份原理风险判断·能独立判断IT操作（如重启服务、修改配置、临时绕过）的GMP影响等级·在紧急情况下能做出“业务可恢复且合规可解释”的决策软技能·强烈的责任心与合规敬畏感·能用非IT语言向质量/生产/工程团队解释技术问题·跨时区协作能力（书面英语+口语沟通）·系统性解决问题，而非单点修复AI相关经验·了解或实践过AI在GMP环境中的应用场景（审计追踪异常检测、预测性维护、LLM辅助文档处理等）·有与数据科学团队协作将AI模型部署到受控环境的经验四、加分项·有系统Owner经验，或曾参与FDA/EMA/NMPA官方检查并现场应答·有混合云GMP系统部署或运维经验熟悉ITIL（事件、变更、问题、配置管理）