Sr. Engineer /Associate Director, Automation

Brief Job Description 工作描述简述 The automation senior engineer is a qualified person in automation engineering and is responsible for oversight of automation systems design and deployment, OT and IT interface configuration, CS lifecycle management, compliance activities. He/she is responsible for L0/L1/L2 OT systems setup/management and support OT & L3 system interface design and monitoring. He/she will mainly focus on new plant project during project phase and will maintain and optimize OT system in BAU phase after project finished. Project Phase: - Supervise new plant OT/computerised systems implementing include L0/L1/L2 OT systems setup/management and support OT & L3 system interface design/integration. - Develops and maintains effective relationships with project team and other stakeholders. - Ensure Automation system compliance with GMPs and other regulations, company policies and procedures. - Review/approve/comments OT related documentation (URS, FS, HDS, SDS, DQ, RTM, FAT/SAT/IQ/OQ protocol) as project required for automation/computer systems design/deployment/validation/compliance. - Serves as a subject matter expert for Automation concerns affecting project implementation. - Identify and mitigate potential risks ensure Commissioning/Qualification/Validation successfully. - Develop OT systems standard and process to meet startup and BAU requirement. BAU Phase: - Ensure OT standard/process are well built, and OT system are well maintained and running smoothly. - Governance and ensure Automation system compliance with GMPs and other regulations, company policies and procedures, change control, qualification, and validation, and Automation systems are in a state of continual readiness for regulatory inspections and internal audits. - Leads/supervises project teams that support implementation and enhancement of automation/information systems and site priorities that reduce operational and compliance risk. Serves as an Automation representative or sub-team leader on cross-functional site projects such as facilities, construction, and engineering projects. - Manages and prioritizes automation/information systems life cycles and upgrades to existing equipment. - Collaborates with Quality, Maintenance, and Operations for successful and on-time resolution of incidents and deviations; enhances quality and effectiveness of manufacturing systems and equipment. - Effectively partners with vendors, systems integrators, contracted personnel, and site business leaders as it applies to capital projects involving automated equipment, control systems, and information systems. - Apply OT/Automation/digital solutions to contribute to autonomous manufacturing strategy. Typical Accountabilities主要职责 Specific Responsibilities/Tasks 具体职责/任务 Application 应用 Consultant and responsible for: - L2 software like SCADA/WCS/RCS/EMS/BMS/RFID/AVDS - Systech and Traceability process data flow - 3rd party system like HighByte - OPC interface node of PI interface/Kepware - L3 system like PI, IBC, TrakSys, Digital Twin Monitoring 监控 Accountable and responsible for: - Application work performance and data quality of traceability - Level 2 system monitoring include IT host OT system - OT cyber security risks - Domain control and time synchronization Consultant for: - PI integration & PI platform monitoring - Interface between OT and L3 system, like MES to SCADA - Interface between OT and OT, like IBC/AGV to equipment - Data Integration between IT and IT, like PI to TrakSys - Backup and restore - Recipe management Incident & Problem 事件与问题 Responsible for incident and problem reporting: - Interface communication failure - Traceability data issue in Systech - PI source system & PI platform issue - OT Cyber security risk incident Audit Readiness Responsible for: - Computerized system management compliance - OT assets & obsolescence & security management - Yearly Application DR Testing Change Management 变更管理 Account and responsible for: - OT and IT interfaces change Consultant and responsible for: - OT configuration minor change implementation - PI Configuration (Tag, AF, EF, templates) - change to existing - PI Interface configuration to L2 systems - change of existing - Traceability systems upgrades - Digital Report templates – changes Support on: - PI Interface configuration to other L3 systems - change of existing - PI Technical Changes through SNOW - reduce operational and compliance risk Automation system project Quality 质量 Consultant for: - Periodic Review on Dev/changes during the year Security 网络安全 Support on: - OT systems/application patching - Deploy global OT security standard/requirement - OT cyber security assessment & Risk reduction (BAU) Education, Qualifications, Experience and Capabilities 教育、资质、经验和能力 Education, Qualification, Experience 教育、资质、经验 Capabilities 能力 - Education: University graduate or above 大学毕业或以上 - Qualifications: Industrial automation 工业自动化 Computerized system 计算机化系统 Information Technology 信息技术 - Experience： 1. ≥ 5 years relevant working experience in Automation positions including manufacturing support and project management. ≥ 5 年自动化相关工作经验包括生产支持和项目管理 2. Experience providing client support and implementing manufacturing control applications in an industrial manufacturing environment, preferably in a GMP environment. 在工业制造环境中提供客户支持和实施制造控制应用程序的经验，最好是在 GMP 环境中。 3. Experience in a regulated industry is highly desired, preferably pharmaceuticals or biotechnology. Knowledge of cGMPs and automation/information systems compliance and validation are required. 非常需要在受监管行业的经验，最好是制药或生物技术。需要了解 cGMP 和自动化/信息系统合规性和验证。 4. Good experience of working cross functionally across with global function and local function team 具备良好的跨部门合作经验，包括与全球职能部门和本地各职能部门的合作。 - Be able to read English technical documentation, written and spoken English is preferred. 能够阅读英文技术资料，最好有英语书写及口语技能 - Automation background and familiar with GMAP5/ 21 CFR Part11, computerized system validation and Project management 自动化背景，熟悉GAMP5/21 CFR Part P11，计算机化系统验证和项目管理 - Good industry automation knowledge, like SCADA, PLC, Robot, AGV, VFD, Servo, industry communication (Modbus, Profinet) 良好的工业自动化知识，如SCADA，PLC，机器人，AGV，变频器，伺服，工业通讯 - Familiar with IT&OT interface, like OPC communication, KEPServerEX, MES and SCADA communication, data acquisition, MQTT, API. 熟悉IT&OT接口，如OPC通讯，KEPServerEX，MES和SCADA通讯，数据采集，MQTT，API。 - Knowledge of AI Computer Vision, MES/PAS-X, OT security, RFID, PAT, Digital Twin, database is preferred. 有人工智能计算机视觉、制造执行系统、OT网络安全、射频识别、过程分析技术、数字孪生、数据库知识更佳。 - Understanding of OSD production and packaging processes is preferred. 最好对口服固体制剂和包装流程有一定了解 - Willing to learn new technology, strong passion to build a future-oriented autonomous/adaptive factory! 乐于学习新技术，对建立一个面向未来的自主/自适应工厂有强烈热情！ - Excellent verbal and written communication skills. Demonstrated interpersonal skills for building relationships with clients and collaborating with colleagues and vendors. 优秀的口头和书面沟通能力。展示了与客户建立关系以及与同事和供应商合作的人际交往能力。 Date Posted 10-Ju