厂房设计专家(工艺/Clean Utility/电气/暖通) Facility Design Expert

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).