制药生产设备管理副总监

/ Job Description 负责生产工艺设备的整体管理及运维，涵盖设备引入、运行维护、技术改造及持续优化，建立高效、合规、可靠的工艺设备管理体系，保障生产稳定运行并持续提升设备可靠性与生产效率。 Responsible for overall management and operations of process equipment, including equipment introduction, operation, maintenance, technical upgrades, and continuous improvement, establishing an efficient, compliant, and reliable process equipment management system to ensure stable production and continuously improve equipment reliability and operational efficiency. ________________________________________ 岗位职责 / Job Responsibilities

1. 01

   工艺设备管理体系建设 负责建立并持续优化工艺设备管理体系，确保符合GMP及公司质量管理体系要求。 Establish and continuously optimize the process equipment management system to ensure compliance with GMP and internal quality management systems. 制定设备管理标准、操作规范及技术标准，推动设备管理标准化与数字化。 Develop equipment management standards, SOPs, and technical guidelines, driving standardization and digitalization. ________________________________________

2. 02

   工艺设备全生命周期管理 负责工艺设备全生命周期管理，包括设备选型、设计评审、采购、安装、调试、验证及退役。 Manage the full lifecycle of process equipment, including selection, design review, procurement, installation, commissioning,

, and retirement. 组织设备预防性维护、校准及再验证工作，确保设备处于受控状态。 Organize preventive maintenance, calibration, and requalification activities to maintain equipment in a validated and controlled state. ________________________________________

3. 03

   工艺设备运维与可靠性提升 负责设备日常运维管理，建立故障响应及维修机制，提高设备可用性。 Manage daily equipment operations and maintenance, establishing effective troubleshooting and repair mechanisms to improve equipment availability. 主导设备故障分析及根因分析，推动CAPA实施，持续降低设备故障率。 Lead root cause analysis of equipment failures and drive CAPA implementation to reduce failure rates. 基于数据分析优化设备运行与维护策略，提升设备OEE。 Optimize maintenance strategies based on performance data to improve equipment OEE. ________________________________________

4. 04

   工艺设备技术支持与工艺协同 支持工艺部门开展工艺开发及优化项目，参与设备参数调试与性能测试。 Support process development and optimization activities, including equipment parameter tuning and performance testing. 确保设备能力满足工艺要求，提高产品质量一致性。 Ensure equipment capability meets process requirements and enhances product consistency. ________________________________________

5. 05

   工程建设及设备改造项目管理 负责新建工艺设备项目及系统改造项目的全流程管理，包括方案评估、设计评审、施工安装及调试。 Lead full lifecycle management of new equipment installation and retrofit projects, including feasibility study, design review, construction, and commissioning. 确保项目按进度、成本及质量目标交付，并符合GMP及验证要求。 Ensure projects are delivered on schedule, within budget, and meet GMP and qualification requirements. 推动项目向生产运维阶段的平稳移交。 Ensure smooth handover from project phase to production and O&M. ________________________________________

6. 06

   自动化及系统集成支持 支持工艺设备相关自动化系统运行与优化（如PLC、SCADA、MES）。 Support operation and optimization of automation systems related to process equipment (e.g., PLC, SCADA, MES). 推动设备与系统的集成及数据完整性管理。 Drive system integration and ensure data integrity of equipment systems. ________________________________________

7. 07

   质量合规与审计支持 确保工艺设备相关活动符合GMP及法规要求。 Ensure all process equipment-related activities comply with GMP and regulatory requirements. 支持监管及客户审计，负责设备相关偏差、变更及CAPA管理。 Support regulatory and client audits, and manage equipment-related deviations, change control, and CAPA. ________________________________________

8. 08

   团队管理与资源规划 建立并管理工艺设备团队，提升团队技术能力与执行能力。 Build and manage the process equipment team to enhance technical capability and execution. 统筹设备运维资源及预算，优化成本与效率。 Manage O&M resources and budget, optimizing cost and efficiency. ________________________________________ 任职要求 / Job Requirements 教育背景 / Education 本科及以上学历，机械、自动化、制药工程、生物工程或相关专业。 Bachelor’s degree or above in Mechanical Engineering, Automation, Pharmaceutical Engineering, Bioengineering, or related fields. ________________________________________ 工作经验 / Experience 具备8年以上制药或相关行业工艺设备管理经验，其中至少3年以上团队管理经验。 Minimum 8 years of experience in process equipment management in pharmaceutical or related industries, with at least 3 years in a leadership role. 具备丰富的工艺设备管理经验，熟悉生物制药工艺及设备应用。 Extensive experience in process equipment management with strong understanding of biopharmaceutical processes. 具备设备全生命周期管理经验。 Solid experience in equipment lifecycle management. 具备工程建设项目或设备改造项目管理经验，能够独立推动项目实施。 Proven experience in managing engineering construction or equipment retrofit projects, with the ability to lead end-to-end project execution. ________________________________________ 专业能力 / Technical Competence 熟悉生物制药工艺设备（如反应器、层析系统、过滤系统等）及其运行原理。 Familiar with biopharmaceutical process equipment (e.g., bioreactors, chromatography, filtration systems) and their operating principles. 具备设备选型、技术评审及工程决策能力。 Strong capability in equipment selection, technical evaluation, and engineering decision-making. 具备设备可靠性管理、故障诊断及持续改进能力。 Strong capabilities in equipment reliability, troubleshooting, and continuous improvement. 熟悉GMP法规及审计要求。 Solid understanding of GMP regulations and audit requirements. ________________________________________ 综合能力 / Leadership & Soft Skills 具备良好的领导力、沟通能力及跨部门协作能力。 Strong leadership, communication, and cross-functional collaboration skills. 具备战略思维及持续改进意识。 Strategic mindset with strong continuous improvement capability.