岗位描述
岗位描述 / Job Description
负责工艺自动化系统的整体管理与运维,包括生产设备自动化系统及信息系统的运行维护、优化升级及工程项目管理,建立稳定、合规、可扩展的自动化体系,支撑生产连续性和数字化发展。
Responsible for overall management and operation of process automation systems, including automation and digital systems for production equipment, covering operation, maintenance, optimization, and engineering project delivery, establishing a stable, compliant, and scalable automation system to support continuous manufacturing and digital transformation.
岗位职责 / Job Responsibilities
1. 自动化管理体系建设
建立并持续优化自动化管理体系,确保符合GMP及数据完整性要求。
Establish and continuously improve the automation management system to ensure compliance with GMP and data integrity requirements.
制定自动化标准、技术规范及系统管理策略,推动标准化与平台化建设。
Develop automation standards, technical guidelines, and system governance strategy, driving standardization and platform development.
2. 自动化系统运维管理
负责生产相关自动化系统运行与维护,包括PLC、SCADA、DCS及MES系统。
Manage operation and maintenance of automation systems, including PLC, SCADA, DCS, and MES.
确保系统稳定运行,及时响应和解决系统故障。
Ensure system stability and timely response to incidents and failures.
建立系统监控及运维机制,提高系统可用性。
Establish monitoring and O&M mechanisms to improve system availability.
3. 系统集成与数字化推进
推动设备、控制系统及信息系统的集成,实现端到端数据流。
Drive integration of equipment, control systems, and IT systems to enable end-to-end data flow.
支持MES、数据平台及数字化项目实施。
Support MES and digital platform deployment and implementation.
推动智能制造及工业数字化能力建设。
Drive smart manufacturing and industrial digitalization initiatives.
4. 故障管理与系统可靠性提升
主导自动化系统故障排查及根因分析。
Lead troubleshooting and root cause analysis of automation system issues.
制定并推动CAPA实施,提升系统稳定性。
Develop and implement CAPA to improve system reliability.
持续优化系统架构及运行策略,降低系统风险。
Continuously optimize system architecture and operation strategy to reduce risks.
5. 工程建设及自动化项目管理
负责自动化相关工程项目及改造项目的全过程管理。
Lead full lifecycle management of automation-related engineering and retrofit projects.
包括需求分析、方案设计、实施、调试及交付。
Cover requirement analysis, solution design, implementation, commissioning, and handover.
确保项目按进度、质量及成本目标交付。
Ensure projects meet schedule, quality, and cost targets.
6. 数据完整性与合规管理
确保自动化系统符合数据完整性(ALCOA+)要求。
Ensure automation systems comply with data integrity principles (ALCOA+).
支持审计及验证活动,确保系统合规。
Support audits and validation activities to ensure compliance.
参与变更控制、偏差及风险评估管理。
Participate in change control, deviation, and risk management.
7. 验证及生命周期管理
支持自动化系统验证,包括CSV及系统生命周期管理。
Support validation of automation systems, including CSV and system lifecycle management.
确保系统在整个生命周期内保持受控状态。
Ensure systems remain in a validated and controlled state throughout lifecycle.
8. 团队管理与跨部门协作
建立并管理自动化团队,提升团队能力与技术深度。
Build and manage the automation team to enhance capability and technical expertise.
与工程、生产、QA、验证及IT团队协同,推动系统稳定运行。
Collaborate with Engineering, Production, QA, Validation, and IT teams to ensure stable operation.
9. 成本与资源管理
负责自动化运维及项目预算管理。
Manage automation O&M and project budgets.
优化系统资源配置及外部供应商管理。
Optimize resource allocation and vendor management.
任职要求 / Job Requirements
教育背景 / Education
本科及以上学历,自动化、计算机、电气工程或相关专业。
Bachelor’s degree or above in Automation, Computer Science, Electrical Engineering, or related fields.
工作经验 / Experience
具备8年以上自动化或相关领域经验,其中至少3年以上团队管理经验。
Minimum 8 years of experience in automation or related fields, with at least 3 years in a leadership role.
具备制药行业自动化系统经验。
Experience in automation systems within pharmaceutical or regulated industries.
具备自动化工程项目或系统改造经验。
Proven experience in automation project or system retrofit management.
专业能力 / Technical Competence
熟悉PLC、SCADA、MES等系统架构及应用。
Familiar with architectures and applications of PLC, SCADA, and MES systems.
具备系统集成及自动化解决方案设计能力。
Strong capability in system integration and automation solution design.
熟悉数据完整性要求及计算机系统验证。
Familiar with data integrity requirements and computer system validation.
具备系统稳定性及故障分析能力。
Strong capability in system reliability and troubleshooting.
综合能力 / Leadership & Soft Skills
具备良好的领导力及跨部门沟通能力。
Strong leadership and cross-functional communication skills.
具备系统性思维及数字化转型意识。
Strong systematic thinking and digital transformation mindset.