锦鲤求职岗位描述
岗位描述 / Job Description
负责原液（DS）生产相关工艺设备的整体管理及技术领导，涵盖细胞培养（上游）及纯化（下游）设备的运行维护、工程建设、可靠性提升及持续优化，建立高效、标准化、可复制的工艺设备管理体系，保障新工厂建设、技术转移及商业化生产顺利推进。
Responsible for overall management and technical leadership of Drug Substance (DS) process equipment, covering both upstream (cell culture) and downstream (purification) systems, including operation & maintenance, engineering projects, reliability improvement, and continuous optimization. Establish an efficient, standardized, and scalable equipment management system to support site start-up, tech transfer, and commercial manufacturing.
岗位职责 / Job Responsibilities
1. 工艺设备管理体系建设
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.
制定设备标准、操作规范及技术标准，推动设备管理标准化和数字化。
Develop equipment standards, SOPs, and technical guidelines, driving standardization and digitalization.
2. 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, qualification, and retirement.
组织设备预防性维护、校准及再验证，确保设备持续处于受控状态。
Organize preventive maintenance, calibration, and requalification to maintain equipment in a validated and controlled state.
3. 工艺设备运维与可靠性提升
负责设备日常运行与维护管理，建立故障响应及维修机制，提高设备可用性。
Manage daily equipment operation and maintenance, establishing effective troubleshooting and repair mechanisms to improve 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维护策略，提升设备运行效率（如OEE）。
Optimize maintenance strategies based on performance data to improve equipment efficiency (e.g., OEE).
4. 工艺技术支持与跨部门协同
支持上游及下游工艺运行，参与工艺放大、验证及持续优化。
Support upstream and downstream process operations, including scale-up, validation, and continuous improvement.
确保设备能力满足工艺需求，提升产品质量一致性。
Ensure equipment capability meets process requirements and enhances product consistency.
5. 工程项目及设备改造管理
负责新建设备及改造项目的全过程管理，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.
推动工程项目向生产运维阶段的平稳移交。
Ensure smooth handover from project phase to production and operations.
6. 自动化与系统集成支持
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).
推动设备与系统集成及数据完整性管理。
Drive system integration and ensure data integrity of equipment systems.
7. 质量合规与审计支持
确保设备相关活动符合GMP及法规要求。
Ensure all process equipment-related activities comply with GMP and regulatory requirements.
负责设备相关偏差、变更及CAPA管理，并支持监管及客户审计。
Manage equipment-related deviations, change control, and CAPA, and support regulatory and client audits.
8. 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、生物工程、制药工程或相关专业。
Bachelor’s degree or above in Mechanical Engineering, Automation, Bioengineering, Pharmaceutical Engineering, or related fields.
工作经验 / Experience
10年以上制药或相关行业经验，其中至少3年以上团队管理经验。
Minimum 10 years of experience in pharmaceutical or related industries, with at least 3 years in a leadership role.
具备原液工艺设备（上游+下游）管理经验，熟悉生物制药生产过程。
Strong experience in DS process equipment (upstream & downstream) with a solid understanding of biopharmaceutical manufacturing.
具备设备全生命周期管理及工程项目管理经验。
Solid experience in equipment lifecycle management and engineering project execution.
专业能力 / Technical Competence
熟悉生物制药工艺设备（反应器、层析系统、过滤及UF/DF系统等）。
Familiar with biopharmaceutical equipment such as bioreactors, chromatography systems, filtration, and UF/DF systems.
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法规及设备验证体系。
Solid understanding of GMP regulations and equipment qualification/validation.
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.
具备较强的执行力与持续改进意识。
Strong execution and continuous improvement mindset.
具备良好的中英文沟通能力。
Good communication skills in both Chinese and English.