Bracco is an international Group active in the healthcare sector and a leader in diagnostic imaging. The Group’s main products are contrast agents sold in over 100 countries, both directly and indirectly through branches, joint ventures and license and distribution agreements.
Responsible for coordinating automation system (PLC/SCADA/DCS/MES, etc.) project implementation, daily operation and maintenance, technical support, and continuous improvement to ensure stable system operation and compliance with cGMP, ISPE, and other regulatory standards, support efficient operations in production, quality control, and warehousing, and assist in driving facility automation and intelligent transformation.
负责工厂自动化系统(PLC/SCADA/DCS/MES等)的项目实施协调、日常运维、技术支持与优化改进工作,确保系统稳定运行并符合cGMP、ISPE等法规标准要求,支撑生产、质检、仓储等环节的高效运作,协助推动工厂自动化与智能化升级。
Main Responsibilities, Activities, Duties and Tasks
主要工作职责,活动和任务
Part I: Technical Support for Automation Systems
自动化系统的技术支持
- Responsible for troubleshooting and repairing automation systems (PLC, SCADA, DCS, BMS, EMS, etc.) in production workshops and utility systems to ensure stable system operation and reduce unplanned downtime; provide support for daily monitoring and inspections when necessary.
负责生产车间及公用工程自动化系统(PLC、SCADA、DCS、BMS、EMS等)的故障诊断与维修,确保系统稳定运行,减少非计划停机;必要时支持日常监控、巡检。
- Develop preventive maintenance plans and execute periodic maintenance tasks including equipment calibration, software backup, and system optimization.
制定预防性维护计划,完成设备校准、软件备份、系统优化等周期性维护任务。
- Provide 7×12-hour on-call technical support on rotating shifts, respond to emergency failures of automation systems on-site, and ensure rapid recovery of critical equipment.
提供7×12小时轮班on-call技术支持,响应现场自动化系统紧急故障,确保关键设备快速恢复。
- Establish equipment failure logs, analyze failure patterns, and develop and implement corrective and preventive actions (CAPA).
建立设备故障台账,分析故障模式,制定并实施纠正预防措施(CAPA)。
- Responsible for or support data integrity maintenance activities for automation systems, including account and privilege management, audit trail configuration, data backup and recovery.
负责自动化系统账户权限管理、审计追踪配置、数据备份与恢复等数据完整性维护工作或支持。
Part II: System Validation and Compliance Support
系统验证与合规支持
- Participate in full lifecycle activities of Computerized System Validation (CSV) for automation systems, including drafting URS, developing FDS/DDS, executing IQ/OQ/PQ testing, and preparing or reviewing validation reports.
参与自动化系统的计算机化系统验证(CSV)全生命周期活动,包括URS起草、FDS/DDS编写、IQ/OQ/PQ测试执行及验证报告编制或审阅。
- Coordinate and support internal audits and external regulatory inspections (NMPA, EMEA, PIC/S, etc.), provide technical documentation and data support related to automation systems.
配合完成内部审计、外部监管检查(NMPA、EMEA、PIC/S等),提供自动化系统相关的技术文档与数据支持。
- Execute change control processes, assess the impact of technical changes on system compliance, and implement verification and qualification after changes.
执行变更控制流程,评估技术变更对系统合规性的影响,实施变更后的验证与确认。
- Ensure all operations comply with data integrity ALCOA+ principles and maintain complete audit trail records.
确保所有操作符合数据完整性ALCOA+原则,维护完整的审计追踪记录。
Part III: Project Implementation and Technical Support
项目实施与技术支持
- Participate in the installation, commissioning, and acceptance of automation systems for new projects or technical renovations and assist in completing Site Acceptance Testing (SAT) and related validation activities.
参与新建项目或技术改造的自动化系统安装、调试与验收工作,协助完成SAT(现场验收测试)以及相关验证工作。
- Support upper manager in project management activities including technical scheme review, supplier technical coordination, and construction quality supervision.
配合上级经理完成技术方案评审、供应商技术对接、施工质量监督等项目管理工作。
- Responsible for interface commissioning and data integration support between automation systems and upper-layer systems such as MES, LIMS, and ERP.
负责自动化系统与MES、LIMS、ERP等上层系统的接口调试与数据对接支持。
- Prepare project-related technical documentation, including commissioning records, operation manuals, and maintenance guidelines.
编制项目相关的技术文档,包括调试记录、操作手册、维护指南等。
Part IV: Process Optimization and Continuous Improvement
流程优化与持续改进
- Identify efficiency bottlenecks and improvement opportunities in automation system operations, propose technical optimization solutions, and assist in implementation.
识别自动化系统运行中的效率瓶颈与改进机会,提出技术优化方案并协助实施。
- Participate in lean manufacturing projects, utilize automation technologies to improve OEE (Overall Equipment Effectiveness), reduce energy consumption and material waste.
参与精益生产项目,运用自动化技术提升OEE(设备综合效率)、降低能耗与物料损耗。
- Collect and analyze automation system operation data, compile operation reports, and provide data support for management decision-making.
收集并分析自动化系统运行数据,编制运行报告,为管理决策提供数据支持。
- Assist in introducing new technology applications (such as predictive maintenance, digital twin, Industrial Internet of Things, etc.) to drive intelligent upgrading.
协助引入新技术应用(如预测性维护、数字孪生、工业物联网等),推动智能化升级。
Part V: Knowledge Management and Training Support
知识管理与培训支持
- Develop and update technical documentation for automation systems, including SOPs, operation manuals, and troubleshooting guides.
- 编写与更新自动化系统SOP、操作手册、故障处理指南等技术文档。
- Provide training on automation system operation and basic maintenance for production operators and equipment technicians/engineers.
- 为生产操作员、设备技师/工程师提供自动化系统操作与基础维护培训。
- Participate in internal technical knowledge sharing sessions to enhance the overall technical capabilities of the team.
- 参与团队内部技术分享,提升团队整体技术能力。
Part VI: Collaboration with Global Engineering Team
与总部工程团队协同
- Proactively establish regular communication mechanisms with the Global Engineering automation team; regularly participate in global technical sharing sessions, standard reviews, and digital project retrospectives to stay abreast of cutting-edge trends in pharmaceutical automation at the earliest opportunity.
主动与Global Engineering自动化团队建立常态化沟通机制,定期参与全球技术分享会、标准评审及数字化项目复盘,第一时间掌握制药自动化领域的前沿趋势。
- Based on the full absorption of global best practices, distill and refining innovative local practices in automation system optimization, energy-saving control, or compliant data management.
在充分吸收全球最佳实践的基础上,提炼本地在自动化系统优化、节能控制或合规数据管理方面的创新实践。
Part VII: Others
其他
- Aware of and comply with the corporate and local Quality/EHS Manual, Quality/EHS Management System, Quality/EHS Management Policy, Quality/EHS Goals, and applicable laws and regulations as they apply to this job type/position.
关注和遵守公司要求的质量、环境健康手册、管理体系和管理政策、目标和该职位的相关的法规要求。
- Other work assigned by superior.
上级领导交代的其他工作。
Education
教育背景
- Bachelor's degree or above in Automation, Electrical Engineering and Automation, Measurement and Control Technology and Instrumentation, Process Equipment and Control Engineering, or related majors; candidates with interdisciplinary backgrounds in Pharmaceutical Engineering, Biochemical Engineering, or Computer Science are preferred.
本科及以上学历,自动化、电气工程及其自动化、测控技术与仪器、过程装备与控制工程等相关专业;具备制药工程、生物化工、计算机科学复合背景者优先。
- Prior experience in foreign-invested pharmaceutical manufacturing enterprises preferred; familiarity with GMP and other compliance requirements in the pharmaceutical industry; experience in automation management in pharmaceutical facilities highly preferred.
具备外资医药生产企业工作经验者优先,熟悉医药行业GMP合规要求,有医药工厂自动化管理经验者优先考虑。
Professional Experience, Knowledge & Technical Skills
工作经验,知识和硬性技能
- 5 years and above of relevant experience in automation, with at least 3 years in GMP-regulated industries such as pharmaceuticals or biopharmaceuticals.
5年及以上自动化相关工作经验,其中至少3年在制药、生物制药等GMP行业。
- Hands-on experience in O&M, optimization, and project management of automation systems (PLC, SCADA, MES, DCS, etc.); experience in implementing automation projects on pharmaceutical production lines preferred.
具备自动化系统(PLC、SCADA、MES、DCS等)的运维、优化及项目管理经验,有医药生产线上自动化项目落地经验者优先。
- Experience participating in external regulatory inspections (NMPA, etc.) and internal audits; familiarity with automation-related compliance requirements and documentation management standards in the pharmaceutical industry preferred.
有参与外部监管(NMPA等)检查及内部审计的相关经验,熟悉医药行业自动化相关合规要求及文件管理规范者优先。
- Participated in at least one complete automation system validation project or facility construction project.
参与过至少1个完整的自动化系统验证项目或工厂建设项目。
- Proficient in one or more mainstream automation platforms (such as Siemens S7/TIA Portal, Rockwell Allen-Bradley, Schneider, Emerson DeltaV, etc.)
熟悉主流自动化平台(如Siemens S7/TIA Portal、Rockwell Allen-Bradley、Schneider、Emerson DeltaV等)中的一种或多种。
- Understanding of pharmaceutical manufacturing processes (e.g., formulation, API production, etc.); familiar with compliance requirements for automation equipment and systems in the pharmaceutical industry; able to ensure automation activities comply with GMP and other regulatory standards.
了解医药生产流程(如制剂、原料生产等),熟悉医药行业自动化设备及系统的合规要求,能够确保自动化工作符合GMP等法规标准。
- Willing to accept necessary overtime and on-site plant inspections; no occupational contraindications.
能够接受必要的加班及工厂现场巡检工作,无职业禁忌证。
- Relevant professional certifications (e.g., Automation Engineer Certificate, PMP, etc.) preferred.
具备相关专业资格证书(如自动化工程师证书、项目管理证书PMP等)者优先。
- Strictly comply with National laws and regulations, EHS and quality management system, abide by the company Code of Conduct, rules and regulations. Ensure that all work behavior conform to company's compliance requirements.
严格遵守国家法律法规,遵守EHS和质量管理体系规定,遵守公司员工行为准则和各项规章制度,确保所有的工作行为符合公司的合规要求。
Contract type:
Fixed Term
If you meet the requirements of this opportunity and would like to join an international group working to improve patients' lives, apply now!
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