自控/电气自动化工程师（制药）Automation / Electrical Engineer (Pharmaceutical)

负责制药生产设备及自动化控制系统的日常维护、故障响应、变更管理与持续优化，保障设备、控制系统及数据采集系统全生命周期稳定运行，全面满足数据完整性法规要求。通过预防性维护、风险评估驱动的改进及技术升级，持续提升设备可靠性、自动化成熟度和生产效率。 Responsible for daily maintenance, fault response, change management, and continuous optimization of pharmaceutical production equipment and automated control systems—ensuring stable operation across the equipment lifecycle while fully complying with Data Integrity

. Through preventive maintenance, risk-based improvements, and technical upgrades, continuously enhance equipment reliability, automation maturity, and overall equipment effectiveness. 岗位职责 Key Responsibilities

1. 01

   设备维护与故障管理 Equipment Maintenance & Fault Management 执行生产设备、PLC/HMI/SCADA/DCS系统及辅助设施的日常巡检、预防性维护与应急维修； Conduct routine inspections, preventive maintenance, and emergency repairs for production equipment, PLC/HMI/SCADA/DCS systems, and auxiliary facilities; 主导故障根本原因分析（RCA），制定并跟踪CAPA（纠正与预防措施），闭环管理偏差； Lead root cause analysis (RCA) of failures, develop and track CAPA (Corrective and Preventive Actions), and close deviations systematically; 建立并维护结构化设备故障数据库，支持趋势分析与可靠性预测。 Establish and maintain a structured equipment failure database to enable trend analysis and reliability prediction.

2. 02

   自动化系统全周期管理 Automation System Lifecycle Management 负责DeltaV、WinCC、iFix等DCS/SCADA系统运维，包括程序备份、版本控制、审计追踪（Audit Trail）验证； Maintain DCS/SCADA systems (e.g., DeltaV, WinCC, iFix), including program backup, version control, and audit trail validation; 管理现场仪表（压力/温度/流量变送器）、执行机构（气动阀/电动阀）及工业通信网络（Modbus/Profibus/EtherNet/IP/OPC UA）； Manage field instruments (pressure/temperature/flow transmitters), actuators (pneumatic/electric valves), and industrial communication networks (Modbus/Profibus/EtherNet/IP/OPC UA); 保障数据采集（DAQ）、存储、备份及电子签名功能符合ALCOA+原则。 Ensure data acquisition (DAQ), storage, backup, and electronic signature functions comply with ALCOA+ principles.

3. 03

   GMP合规与计算机化系统验证（CSV） GMP Compliance & Computerized System Validation (CSV) 主导或深度参与URS、FS、DS、IQ/OQ/PQ、DQ及CSV方案编制与执行； Lead or deeply participate in URS, FS, DS, IQ/OQ/PQ, DQ, and CSV protocol development and execution; 应用GAMP5框架开展风险评估（RA）、变更控制（Change Control）及供应商管理（FAT/SAT）； Apply GAMP5 framework for risk assessment (RA), change control, and supplier management (FAT/SAT); 确保自动化系统持续满足GMP附录《计算机化系统》及数据完整性法规要求。 Ensure automated systems consistently meet GMP Annex “Computerized Systems” and Data Integrity regulatory requirements.

4. 04

   项目交付与技术升级 Project Delivery & Technical Modernization 主导自动化改造项目（如老旧PLC替换、HMI界面升级、SCADA系统迁移）的技术方案设计与实施； Lead technical design and implementation of automation modernization projects (e.g., legacy PLC replacement, HMI interface upgrade, SCADA system migration); 参与新设备选型、FAT/SAT测试、安装调试及GMP符合性验收； Participate in new equipment selection, FAT/SAT testing, commissioning, and GMP-compliant acceptance; 协调罗克韦尔（Rockwell）、西门子（Siemens）、欧姆龙（Omron）等供应商提供技术支持与知识转移。 Coordinate technical support and knowledge transfer from vendors such as Rockwell, Siemens, and Omron.

5. 05

   预防性维护体系优化 Preventive Maintenance System Optimization 编制基于设备关键性（Criticality）与失效模式（FMEA）的PM计划，并动态优化； Develop PM plans based on equipment criticality and failure modes (FMEA), with dynamic optimization; 利用报警日志、运行参数趋势分析识别潜在失效风险，推动预测性维护（PdM）落地； Identify potential failure risks via alarm logs and operational parameter trends, enabling predictive maintenance (PdM); 将MTBF（平均故障间隔时间）、MTTR（平均修复时间）纳入KPI考核，降低非计划停机率。 Incorporate MTBF (Mean Time Between Failures) and MTTR (Mean Time To Repair) into KPIs to reduce unplanned downtime.

6. 06

   能力建设与持续改进 Capability Building & Continuous Improvement 为生产、质量、验证团队提供自动化系统操作、故障诊断及GMP合规培训； Deliver training on automation system operation, fault diagnosis, and GMP compliance to production, quality, and validation teams; 编写/更新SOP、WI、BOM及设备技术档案，确保文件受控且可追溯； Author/update SOPs, WIs, BOMs, and equipment technical files to ensure controlled and traceable documentation; 推动精益自动化（Lean Automation）项目，如批次指令自动下发、电子批记录（EBR）集成、无纸化操作。 Drive Lean Automation initiatives, e.g., automatic batch instruction dispatch, Electronic Batch Record (EBR) integration, and paperless operations. 任职资格 Qualifications 教育背景：自动化、电气工程、机电一体化、控制科学与工程等相关专业本科及以上学历； Education: Bachelor’s degree or higher in Automation, Electrical Engineering, Mechatronics, Control Science & Engineering, or related fields; 工作经验：3年以上制药/生物制药行业自动化系统运维或项目实施经验，具备至少1个完整CSV验证项目经历； Experience: Minimum 3 years’ hands-on experience in automation system operation or project implementation within pharmaceutical/biotech manufacturing, including at least one full CSV validation cycle; 核心技能： Core Competencies: ✓ 精通西门子S7系列、罗克韦尔Logix平台、欧姆龙NJ/NX系列PLC编程与故障诊断； ✓ Proficient in PLC programming & troubleshooting for Siemens S7, Rockwell Logix, and Omron NJ/NX platforms; ✓ 熟练使用DeltaV、WinCC、iFix等DCS/SCADA组态与数据管理； ✓ Skilled in configuration and data management for DeltaV, WinCC, and iFix DCS/SCADA systems; ✓ 深入理解GAMP5、21 CFR Part 11、EU Annex 11及中国GMP附录《计算机化系统》； ✓ In-depth understanding of GAMP5, 21 CFR Part 11, EU Annex 11, and China GMP Annex “Computerized Systems”; ✓ 具备仪表校准、传感器选型、通信协议调试及网络安全基础能力。 ✓ Capable of instrument calibration, sensor selection, communication protocol debugging, and basic cybersecurity practices.