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。