AstraZeneca

Sr. Engineer /Associate Director, Automation

China - Wuxi Full time

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

04-Mar-2026

Closing Date

29-Jun-2026

AstraZeneca embraces diversity and equality of opportunity.  We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.  We believe that the more inclusive we are, the better our work will be.  We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.  We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.