天津招聘

职位描述：
SUMMARY 概述
Full time maintenance for the equipment and facilities for the ICT Bio facilities in China. This function is responsible for both the current research site as well as future pilot- and commercial-scale facilities.
全职负责斯丹赛公司在国内工厂设备设施的维护。包括现有研发工厂和将来中式以及商业化生产的工厂。

1. Active participation in the development and implementation of the Company & department Quality Management System with specific responsibility for facility systems and critical equipment: routine maintenance and response to breakdown maintenance.
参与开发和实施公司以及部门的质量管理系统，厂务和关键设备的常规维护和应急维修。
2. Member of the cross-functional Facilities Department.
工程和验证部门的成员。
3. Supervision of ICT Maintenance personnel
管理工厂维护以及机修团队。
4. Ensuring the Company’s direct-impact equipment are maintained in a validated state.
确保公司核心的自动化系统的维护在验证状态
5. Management of specialist contractors and vendors to maintain equipment.
管理专业承包商和供应商。
6. First point of call for the Company’s facility systems including:
公司设施的服务响应：
a. Production and Process Development equipment
生物工艺设备，工艺开发设备
b. HVAC (Classified Cleanrooms and general areas), Water for Injection systems
暖通空调（洁净室和公共区域），注射用水系统
c. Pure Steam Systems, Compressor Dry Air systems, Specialist gas systems
纯蒸汽，压缩空气，特种气体系统
d. Process Glycol, Chilled water system, Cooling water system, Boiler system
工艺乙二醇，冷冻水，冷却水，燃气锅炉
e. Waste Water Treatment systems, Electrical power system (included emergency generator)
废水处理系统，电力系统（应急发电机）

ESSENTIAL FUNCTIONS 主要职责
Essential functions include, but are not limited to the following:
主要职责包括但不限于：
? Site Safety工厂安全
o Developing and maintaining a culture of safe working practices through personal leadership and establishing standard procedures for safety management.
管理和建立安全管理操作规程以发展和维护公司的安全文化。
o Enforcing a system for job safety assessments and issuing permits-to-work including lock-out tag-out of energized and hazardous systems. Zero lost-time injuries
实施工作安全评估，工作许可包括挂牌上锁程序，实现零损失工时事故。
? Maintenance of Facilities and equipment 设施设备的维护
o Maintaining the operational state of facility systems incompliance with Good Manufacturing Practice (GMP).
按照GMP规范，维护设备系统的运作状态
o Preparing and managing the schedule of preventative maintenance activities for the site. Priority being core manufacturing facility and utilities and coordination with Production and QC departments.
计划和管理防护检测日程，协调生产，QC部检修核心生产设备
o Coordination of specialist service providers and vendors to execute the maintenance program. Breakdown repair and trouble-shooting of equipment and facilities.
协调供应商承包商执行安全程序，设施设备的故障诊断和应急维修。
o On call (SMS) for emergency response to system alarms.
实时响应系统报警
o Issue and management of Work Orders.
签署和管理工单
o Annual, half year, quarterly, monthly, weekly maintenance of facility systems.
定期对设施系统进行防护检修
o Managing the inventory of critical spare parts to ensure that foreseen mechanical failures of utilities can be rectified within 24 hours.
管理关键备件的库存，确保设施能24小时内修复故障
o Managing the programmed maintenance plan for the site covering cleaning and renovation of buildings and grounds to keep them in a high standard.
管理大楼清洁和建筑翻新的维护计划，维持高标准
o Minor redesign and capital projects to improve operation status.
改造小型项目以提高运作状态

? Quality 质量
o Preparing standard operating procedures and associated records for management and execution of the maintenance program.
制定操作规程，管理相关记录，执行维修程序
o Raising and/or resolving investigations for quality incidents related to performance of facilities and equipment.
调查并解决设备设施运行中的质量事故
o Complying with, and continuously improving, the Company Quality Management System.
遵循并不断改进公司的质量管理系统
? Design 设计
o Review and mark-up of design drawings to provide practical and easily maintained design. Recommend and approve preferred vendors for equipment and spares
审核，标注设计图纸，提供实际，易维护的设计，批准设备备件的推荐供应商
o Selection of critical and routine maintenance spare parts such as gas filters, HEPA filters, motors, electrical components, and chemical dosing consumables.
选择关键和常规的维修备件，例如气体过滤器，高效过滤器，电机，电器，化学消耗品
o Preparing and revising documented User Requirement, Functional Specifications, and Detailed Specifications.
准备和修订用户需求，功能规格和详细规格表
o Managing specialist design consultants and liaising with vendors.
管理专业设计顾问，协调供应商
o Selecting and installing instrumentation such as temperature, pressure, and flow controllers.
选型和安装仪器如温度压力，流量等
? Management 管理
o Preparing weekly and monthly progress reports.
提交周报月报进度报告。
o Management of Engineers and Technicians including setting objectives and review of performance.
管理工程师和技工的目标设定和绩效考核
o Selection and supervision of specialist contractors.
选择和管理专业承包商。
o Approval of operating expenditure in line with approved budget and authority level.
在预算和授权范围内管理费用预算。
o Providing technical and financial input to capital expenditure requests for site improvement and renovation projects.
对工厂改扩建项目的资本支出提供技术和财务支持
o Contributing positively to Company morale.
积极维护公司形象 举报 分享

上海斯丹赛生物技术有限公司定位于成为全球细胞治疗及再生医学领域的领航者，致力于服务科技创新和人类健康，在细胞治疗和基因编辑等领域，共递交专利申请多项并多次发表国际水平文章，在CAR-T细胞治疗领域中已走在行业前列。针对难治复发性白血病完全缓解率达85%，达到国际领先水平。在治疗淋巴瘤患者中取得了显著的临床效果，同时实体瘤的研发也已进入临床阶段。斯丹赛现已开始布局全球化战略，同时向中美两国递交了注册申请，已获批中国药监局临床试验，并已开展药物临床试验。公司计划两年内完成纳斯达克上市。