生产设备管理负责人 Head of Process Equipment Management

Job Description: 作为生产设备管理负责人，负责生产设备（原液，制剂，药械组装等等）与自动化系统全生命周期管理、新设备导入、运维管理、设备可靠性管理及团队管理，为生产线稳定、合规、高效运行提供全面设备工程支撑。 As the Head of Process Equipment Management, responsible for the full lifecycle management of process equipment (DS, DP, DAC, etc.) and automation systems, new equipment introduction, operation and maintenance management, equipment reliability management, and team management, providing comprehensive equipment engineering support for the stable, compliant, and efficient operation of production line. 岗位职责 Job Responsibilities

1. 01

   生物制药原液与制剂设备全生命周期管理：负责生物反应器，层析系统，超滤与渗滤系统，灌装线，冻干机等核心工艺设备与相关辅助设备，覆盖设计选型、安装运行确认，预防性维护，维修，优化改善，直至退役全流程管理。 Full lifecycle management of biopharmaceutical DS and DP equipment: Responsible for core process equipment and related auxiliary equipment such as bioreactors, chromatography systems, UFDF systems, filling lines, freeze dryers, covering design selection, installation and operation confirmation, preventive maintenance, repair, optimization and improvement, and all the way to retirement.

2. 02

   自控系统全周期管理：负责DCS/PLC/SCADA、EMS及过程仪表（温度、压力、DO等）运维，处理报警与异常，确保系统稳定、数据准确；推进自控系统升级与数字化改造，适配工艺变更需求。 Full lifecycle management of the automatic control system: Responsible for operation and maintenance of DCS/PLC/SCADA, EMS, and process instruments (temperature, pressure, DO, etc.), handling alarms and exceptions to ensure system stability and data accuracy; Promote upgrades and digital transformation of automatic control systems to meet process change

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3. 03

   设备与自控系统可靠性提升：负责建立并优化预防性维护计划（PM）、维修（CM）、备件策略，提升设备与自控系统可靠性。制定关键设备与系统业务持续计划（BCP）、灾难恢复计划（DRP），确保生产项目按计划进行。 Reliability improvement of equipment and automation systems: Responsible for establishing and optimizing preventive maintenance plans (PM), corrective maintenance (CM), and spare parts strategies to enhance the reliability of equipment and automation systems. Develop Business Continuity Plans (BCP) for critical equipment and systems and Disaster Recovery Plans (DRP) to ensure production projects proceed as scheduled.

4. 04

   GMP合规与审计：确保相关文件（SOP、维护维修记录等）完整合规、按GMP要求保存。负责客户与官方审计准备与迎审工作。 GMP Compliance and Audit: Ensure that relevant documents (SOPs, maintenance and repair records, etc.) are complete and compliant, and stored according to GMP requirements. Responsible for client and regulatory audit preparation and auditing work.

5. 05

   团队与跨部门管理：管理设备与自控团队，负责招聘、培训、绩效与梯队建设；协同生产、质量、EHS等部门，高效解决跨领域问题，保障生产连续性。 Team management and cross-departmental management: Manage equipment and automation team, responsible for recruitment, training, performance, and pipeline building; Collaborating with departments such as production, quality, and EHS to efficiently solve cross-domain issues and ensure production continuity.

6. 06

   成本与安全管理：优化备品备件库存与采购，控制维护成本；推进设备节能降耗，落实EHS要求，排查安全隐患，杜绝重大事故。 Cost and Safety Management: Optimize spare parts inventory and procurement, and control maintenance costs; Promote energy conservation and consumption reduction in equipment, implement EHS requirements, inspect safety hazards, and prevent major accidents. 任职要求 Job Requirements

7. 01

   学历与专业：本科及以上，机械工程、自动化、生物制药工程等相关专业，硕士优先。 Education and major: Bachelor's degree or above, majoring in mechanical engineering, automation, biopharmaceutical engineering, or related fields; master's degree preferred.

8. 02

   经验要求：10年以上生物制药/CDMO行业设备与自控管理经验，5年以上团队管理经验；有生物制药原液与制剂设备运维及EMS系统管理经验优先。 Experience requirement: Over 10 years of equipment and automation management experience in the biopharmaceutical/CDMO industry, and more than 5 years of team management experience; Experience in operating and maintaining DS and DP equipment and EMS system management is preferred.

9. 03

   专业能力：精通GMP环境下设备与自控系统验证全流程，掌握FMEA、PSP、TPM等风险分析与问题解决方法，设备管理相关工具。 Professional Skills: Proficient in the entire process of equipment and automation system verification under GMP environments, proficient in risk analysis and problem-solving methods such as FMEA, PSP, TPM, and related equipment management tools.

10. 04

    语言与工具：英语流利，可胜任中英书面与口头沟通；熟练使用办公协作工具。Language and Tools: Fluent in English, able to communicate both in written and spoken Chinese-English; Proficient in using office collaboration tools.