锦鲤求职岗位描述
岗位概述（Overview）
作为工程部技术专家，负责生物生产厂房的洁净公用设施（Clean Utility），电气和自动化系统，暖通与洁净室系统及总体工艺布局的设计、标准制订与技术把关，支持国内外新建与改造项目并推动技术能力建设。
Serve as technical Expert in the engineering organization, responsible for Power system,clean utilities, HVAC and cleanroom systems, and overall process layout for pharmaceutical/biologics manufacturing facilities. Establish standards, perform technical review, support domestic and overseas greenfield and retrofit projects, and drive technical capability development.
主要工作职责（Key Responsibilities）
负责工厂改造与扩建项目的设计方案制定、技术可行性评估、施工图审核及现场设计支持，确保设计满足GMP/ISO等法规与质量要求。
Lead design development, feasibility assessment, construction drawing review and on-site design support for plant retrofit and expansion projects, ensuring compliance with GMP/ISO and regulatory quality requirements.
担任项目技术负责人，参与项目管理（进度、成本、质量、安全），协调施工、设备供应与工艺团队，推动项目按计划交付。
Act as technical lead for projects, participating in project management (schedule, cost, quality, safety), coordinating contractors, equipment vendors and process teams to drive on-time delivery.
为海外项目提供设计支持与持续改进建议（包括工艺需求匹配、法规要求差异、能耗与运行成本优化）。
Provide design support and continuous improvement recommendations for overseas projects (including localization, regulatory differences, energy and operating cost optimization).
支持重大项目的设计审核（design review）与风险评估，作为技术评审小组成员出具专业意见。
Support design reviews and risk assessments for major global engineering projects, serving as a technical reviewer and providing professional recommendations.
为暖通、洁净室、洁净公用设施与工艺布局等各专业工程师提供技术指导、评审培训与能力提升，制定设计标准与验收要点。
Provide technical guidance, review training and competency development for discipline engineers (HVAC, cleanroom, clean utilities, process layout), and develop design standards and acceptance criteria.
参与洁净室及系统运行验证(如洁净度测试、气流/压差验证、BAS调试)的技术支持，并协助推进工程与工艺的联动验证工作。
Participate in technical support for cleanroom and system qualification (e.g., cleanliness testing, airflow/pressure validation, BAS commissioning) and assist in integrated engineering-process qualification activities.
推动BIM/数字化设计工具在项目中的应用，推进设计优化与工程交付效率提升。
Drive adoption of BIM/digital design tools in projects to optimize design and improve engineering delivery efficiency.
任职要求（Qualifications）
工程类本科及以上学历（给排水、暖通、化工、机电、洁净工程等相关专业优先）。
Bachelor’s degree or above in engineering (HVAC, Plumbing, Chemical, Mechanical, Cleanroom Engineering or related disciplines preferred).
10年以上制药/生物制药厂房设计与项目管理经验，具备暖通、洁净室与洁净公用设施全流程设计经验，曾主导或深度参与过改造类项目优先。
Minimum 10 years’ experience in pharmaceutical/biologics facility design and project management, with end-to-end experience in HVAC, cleanroom and clean utilities design; prior leadership on retrofit projects preferred.
熟悉GMP、PIC/S、FDA、EU GMP等药厂法规与洁净室相关标准（ISO 14644、EU Annex 1等）；熟悉ASHRAE和能源优化原则者优先。
Strong knowledge of GMP, PIC/S, FDA, EU GMP and cleanroom standards (ISO 14644, EU Annex 1); familiarity with ASHRAE and energy optimization principles is a plus.
熟悉WFI、纯化水、洁净蒸汽、压缩空气、氮气等洁净公用设施系统设计与运行要求。
Familiar with design and operational requirements of WFI, purified water, clean steam, oil-free compressed air, nitrogen and other clean utilities.
熟练使用AutoCAD、Revit/BIM、HVAC设计及仿真软件（如HAP、Trace、Fluent/CFD等），能够支持工程图纸及BIM模型审核。
Proficient with AutoCAD, Revit/BIM and HVAC design/simulation tools (e.g., HAP, Trace, Fluent/CFD), able to review engineering drawings and BIM models.
有设计院或工程管理公司经验者优先；具备跨区域项目协调与海外项目工作经验更佳。
Experience in a design institute or engineering management company preferred; cross-regional coordination and overseas project experience is an advantage.
优秀的沟通协作与英语书面/口语能力，能支持海外项目沟通与技术文件编写。
Excellent communication and collaboration skills with strong written and spoken English to support overseas project communication and technical documentation.
具备团队培养能力，愿意承担技术带教与标准体系建设工作。
Demonstrated ability to mentor and develop team members and to contribute to standards and systems development.
优先条件（Preferred）
注册工程师资质（如一级注册/工程师）或相关行业认证。
Registered Professional Engineer or relevant industry certifications.
有生物制药一次性使用系统、洁净厂房反应/分离工艺布局经验。
Experience with single-use systems and process layouts for biologics manufacturing (reaction/separation).