锦鲤求职岗位描述
岗位描述 / Job Description
负责公司公用设施、生产设备及自动化系统的整体运维管理，建立高效、合规、可靠的工程运维体系，保障生产系统稳定运行，并持续提升设备可靠性、运行效率与成本控制水平。
Responsible for overall operations and maintenance (O&M) management of utilities, production equipment, and automation systems, establishing an efficient, compliant, and reliable engineering O&M system to ensure stable production, while continuously improving equipment reliability, operational efficiency, and cost control.
岗位职责 / Job Responsibilities
1. 运维体系与工程管理
负责建立并持续优化公司工程及运维管理体系（涵盖公用设施、生产设备及自动化系统），确保符合GMP、EHS及公司运营要求。
Establish and continuously optimize the engineering and O&M management system (covering utilities, process equipment, and automation systems) to ensure compliance with GMP, EHS, and internal operational standards.
统筹设备管理策略、技术标准及工程规范，推动工程管理与运维管理一体化。
Lead equipment management strategies, technical standards, and engineering governance, integrating engineering management with O&M practices.
制定运维策略（如预防性维护、预测性维护等），推动运维数字化与标准化，提升系统可靠性与可用性。
Develop maintenance strategies (e.g., preventive and predictive maintenance), and drive digitalization and standardization of O&M to enhance system reliability and availability.
2. 工程建设及改造项目管理
负责公用设施、生产设备及自动化相关工程建设项目及改造项目的整体管理，包括方案评估、设计评审、施工管理、调试及交付。
Lead engineering construction and retrofit projects related to utilities, process equipment, and automation systems, including feasibility study, design review, construction management, commissioning, and handover.
推动项目按进度、成本及质量目标交付，确保符合GMP及验证要求（C&Q/IQ/OQ/PQ）。
Ensure projects are delivered on schedule, within budget, and in compliance with quality objectives and GMP/qualification requirements (C&Q/IQ/OQ/PQ).
协调EPCM、供应商及内部多部门资源，确保项目顺利实施并实现平稳移交至运维阶段。
Coordinate EPCM, vendors, and cross-functional teams to ensure successful project execution and smooth transition to O&M.
3. 公用设施运维管理
负责GMP及非GMP公用系统（如HVAC、WFI、压缩空气、蒸汽及能源系统）的日常运维、维护与优化。
Lead the daily operation, maintenance, and optimization of GMP and non-GMP utility systems (e.g., HVAC, WFI, compressed air, steam, and energy systems).
建立公用设施监控、巡检及应急响应机制，确保关键系统稳定运行及快速恢复能力。
Establish monitoring, inspection, and emergency response mechanisms to ensure stable operation of critical systems and rapid recovery capability.
4. 生产设备运维管理
负责生产设备全生命周期运维管理，包括安装、调试、维护、校准及退役策略。
Manage the full lifecycle O&M of production equipment, including installation, commissioning, maintenance, calibration, and retirement strategies.
建立设备预防性维护与故障管理机制，推动设备可靠性持续提升，降低故障率与停机时间。
Establish preventive maintenance and failure management systems to continuously improve equipment reliability and reduce downtime.
推动设备技术标准化、模块化及持续改造升级。
Drive standardization, modularization, and continuous improvement and upgrade of process equipment.
5. 自动化系统运维
负责自动化系统（如PLC、SCADA、MES等）的运行维护、优化升级及故障处理。
Lead the operation, maintenance, optimization, and troubleshooting of automation systems (e.g., PLC, SCADA, MES).
推动自动化系统稳定性与数据完整性管理，支持生产连续性及数字化转型。
Enhance system stability and data integrity management to support continuous production and digital transformation.
6. 故障管理与可靠性提升
主导重大设备及系统故障分析，制定并推动CAPA闭环，防止问题重复发生。
Lead root cause analysis of major equipment and system failures and drive CAPA implementation to prevent recurrence.
基于数据分析持续优化运维策略，提升设备效率及整体生产效率。
Continuously optimize maintenance strategies based on data analysis to improve equipment efficiency and overall operational performance.
7. 质量合规与审计支持
确保所有运维活动符合GMP及相关法规要求，支持监管及客户审计。
Ensure all O&M activities comply with GMP and regulatory requirements and support regulatory and client audits.
负责偏差、变更、风险评估及CAPA管理在运维领域的实施。
Lead deviation, change control, risk assessment, and CAPA implementation within the O&M scope.
8. 团队管理与成本控制
搭建并管理工程运维团队，优化组织架构与能力模型，提升团队整体能力。
Build and manage the engineering O&M team, optimizing organizational structure and competency to enhance overall team capability.
与生产、质量、验证、采购等部门协同，确保运维活动与生产需求一致。
Collaborate with Production, QA, Validation, Procurement and other functions to align maintenance activities with production needs.
负责运维预算管理及成本优化，提升资源利用效率。
Manage O&M budget and optimize cost efficiency.
建立备件管理体系，确保关键设备备件可用性并降低库存成本。
Establish a spare parts management system to ensure availability of critical spares while controlling inventory costs.
任职要求 / Job Requirements
教育背景 / Education
本科及以上学历，机械、电气、自动化、暖通或相关工程专业。
Bachelor’s degree or above in Mechanical, Electrical, Automation, HVAC, or related engineering disciplines.
工作经验 / Experience
具备8年以上制药或相关行业工程运维经验，其中至少3年以上团队管理经验。
Minimum 8 years of engineering O&M experience in pharmaceutical or related industries, with at least 3 years in a leadership role.
具备扎实的工程及设备管理经验，熟悉设备全生命周期管理（设计选型、安装、调试、验证、维护及退役）。
Solid experience in engineering and equipment management, with strong knowledge of equipment lifecycle management (design, selection, installation, commissioning, qualification, maintenance, and retirement).
具备工程建设项目或系统改造项目管理经验，能够独立推动项目全流程实施。
Proven experience in managing engineering construction or retrofit projects, with the ability to lead end-to-end project execution independently.
专业能力 / Technical Competence
具备工程项目管理能力，熟悉工程项目全过程，包括立项、设计、施工、调试、验收及移交。
Strong engineering project management capability, familiar with full project lifecycle including initiation, design, construction, commissioning, acceptance, and handover.
熟悉设备、公用设施及自动化系统技术要求，并具备工程技术评审与决策能力。
Familiar with technical requirements of equipment, utilities, and automation systems, with strong capability in technical evaluation and 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 management, 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.
具备战略思维及成本优化意识，能够推动组织持续改进。
Strategic mindset with strong cost optimization awareness and ability to drive continuous improvement.