工程项目管理助理主任/副主任 | Project Management Assis/Associate Director

focuses on project planning, design management, construction coordination, and engineering delivery, covering multi-disciplinary facility design (e.g., civil construction, HVAC systems, MEP engineering, clean utilities, water systems, and waste management). The candidate will ensure all projects strictly comply with GMP standards and regulatory

, meet process needs and long-term operational goals, and promote facility renovation to enhance production efficiency and fulfill scalability needs.

主要职责 | Key Responsibilities

1. 项目规划与协调 | Project Planning & Coordination

• 代表用户端参与厂房建设项目的可行性研究、总体规划和投资分析，协同项目建设团队明确新厂房的目标、时间节点及预算。

Represent the user side in feasibility studies, master planning, and investment analysis for facility construction, and collaborate with the project construction team to define objectives, timelines, and budgets for new facilities.

• 制定详细的项目计划，涵盖资源分配、里程碑时间表及风险管理，协同相关团队监督落实执行并及时调整。

Develop detailed project plans, including resource allocation, milestone schedules, and risk management strategies, and work with relevant teams to ensure implementation and necessary adjustments.

• 协同工程、制造及财务部门的跨部门需求，确保项目技术目标与预算可行性平衡。

Collaborate with Engineering, Manufacturing, and Finance departments on cross-functional requirements to ensure a balance between technical goals and budget feasibility.

2. 工程设计管理 | Facility Design Management

• 协同项目建设团队推进厂房的多学科设计工作，包括：

Work alongside the project construction team to advance multi-disciplinary facility design, including:

• 土建工程（Civil Construction）：厂房建筑基础、结构设计和功能区划分。

Facility foundation, structural design, and functional zoning of building areas.

• 暖通空调系统（HVAC Systems）：洁净室气流组织、湿度和温控设计，符合 GMP 及法规标准。

Cleanroom airflow, humidity, and temperature control design per GMP and regulatory requirements.

• 机电工程（MEP）：电力分配、机械支持系统及机房布局的整合与优化。

Power distribution, mechanical support systems, and optimization of equipment room layouts.

• 洁净公用系统及废物处理（Clean Utilities & Waste Handling Systems）：涉及纯化水 (WFI)、洁净气体、蒸汽及污水管理系统的设计实施。

Design and implementation of clean utilities such as WFI, clean gases, steam, and wastewater management systems.

• 废气与排放管理（Emission and Disposal Systems）：符合环保法规要求的废气排放与处理设施设计与管理。

Design and management of emission control systems that meet environmental regulations.

• 与全球工程团队共同设计高效支持未来扩产需求的灵活设施，支持工艺扩展及多产品生产要求。

Coordinate with the Global Engineering team to design flexible facilities that efficiently support scalability, process expansion, and multi-product manufacturing needs.

3. 现有工厂改造与扩建 | Renovation and Expansion of Existing Facilities

• 负责现有工厂的改造与扩建项目，包括生产设施升级、公用工程系统优化（如蒸汽、纯化水系统、废水处理设施）及工艺功能区改造。

Manage renovation and expansion projects for existing facilities, including production infrastructure upgrades, optimization of utility systems (e.g., steam, WFI systems, wastewater facilities), and remodeling of process functional areas.

• 规划并执行改造项目，确保所有设计与实施工作严格符合 GMP 和法规要求，同时优先满足现有生产运营需求。

Plan and execute renovation projects while ensuring all design and implementation activities strictly comply with GMP and regulatory requirements, prioritizing the needs of ongoing production operations.

• 协调多方资源，优化项目实施时间表，减少对现有生产流程的影响并确保扩展项目的高质量交付。

Coordinate multi-party resources to optimize project timelines, minimize disruption to existing production processes, and ensure high-quality delivery of expansion projects.

4. 施工协调与项目交付 | Construction Coordination & Project Handover

• 协同项目建设团队推动施工阶段，与设计团队保持紧密联系，确保施工执行符合设计要求。

Collaborate with the project construction team during the construction phase to ensure execution aligns with design requirements.

• 推动施工、调试与验证工作（CQV），确保项目在保质保量的前提下按计划推进。

Drive construction, commissioning, and qualification (CQV) work to ensure projects proceed as planned with quality and efficiency.

• 监控施工进度与消耗成本，确保项目交付满足预算和时间要求。

Monitor construction progress and costs to ensure project delivery meets budget and schedule expectations.

任职要求 | Qualifications

学历要求 | Education

• 工程管理、建筑设计、机械工程、生物工程、化学工程或相关领域本科及以上学历，硕士优先。

Bachelor’s degree or above in Engineering Management, Architectural Design, Mechanical Engineering, Bioengineering, Chemical Engineering, or related fields. Master’s degree preferred.

经验要求 | Experience

• 至少 5 年生物制药厂房项目管理经验，具备设计、施工、调试及验证的全生命周期经验，包括现有设施的改造或扩建经验优先。

Minimum of 5 years of project management experience in biopharmaceutical facilities, with full lifecycle involvement in design, construction, commissioning, and validation. Prior experience in renovation or expansion of existing facilities is preferred.