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director of engineering.

职位概述

职位概览

    职位概述


    about the job.

    1. Site Safety and Environmental compliance 工地安全及符合环保规定

    1) Developing and maintaining a culture of safe working practices through personal leadership and establishing standard procedures for safety management. 通过个人领导和建立安全管理的标准程序,发展和维护安全工作文化。

    2) Enforcing a system for job safety assessments and issuing permits -towork including lock-out tag-out of energized and hazardous systems. Participation in site safety committee as required. 执行工作安全评估和发放工作许可证制度,包括封锁带电和危险系统。按 要求参加现场安全委员会。

    3) Coordinating applications for safety and environmental compliance permits and enforcing compliance with permit requirements. 协调安全和环境合规许可的申请,并强制执行许可要求。

    2. Design Management 设计管理

    1) Coordinating preparation of documented User Requirement Specifications. 协调编制文件化的用户需求规范。

    2) Management of specialist design consultants and liaison with vendors to design and specify systems. 管理专业设计顾问,并与供应商联络以设计和指定系统。

    3) Reviewing and approval of design packages for facilities and utilities. 审查和批准设施和公用设施的设计包。

    3. Engineering Maintenance工程维修

    1) Managing core site utilities to support continuous operation. 管理核心站点公用事业以支持持续运营。

    2) Preparing and managing the schedule of preventative maintenance and calibration activities for the site. Priority being core manufacturing facility and utilities and coordination with Production and QC departments. 准备和管理现场预防性维护和校准活动的时间表。优先考虑核心制造设施 和公用事业,并与生产和质量控制部门协调。

    3) Managing timely response to break-down events. 管理对故障事件的及时响应。

    4) 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,确保公用事业公司可在 24 小时内纠正已预见的机 械故障。

    5) Managing the security and access control for the site including induction and certification of contractors. 管理现场的安全和访问控制,包括承包商的入职和认证。

    6) Preparing and managing the programmed maintenance plan for the site covering cleaning and renovation of buildings and grounds to keep them in a high standard. 编制和管理现场的程序化维护计划,包括建筑物和地面的清洁和翻新,以 保持高标准。

    7) Contributing to investigation of quality investigations related to performance of facility and equipment. 协助调查与设施和设备性能相关的质量调查。

    4. Validation验证

    1) Support and assist in establishing and maintaining the system of testing for facilities, utilities, and equipment based on the CBL Biotech corporate standards. 支持并协助建立和维护基于 CBL 生物技术公司标准的设施和设备测试系统。

    2) Support and assist in the preparation of validation of equipment, facilities, and utilities. 支持和协助准备设备和公用设施的验证。

    3) Support and assist in coordinating execution of testing with vendors and CBL personnel. 支持并协助与供应商和 CBL 人员协调测试的执行。

    4) Ensuring the Company’s GMP utilities systems are maintained in a validated state. 确保 GxP 运营中使用的所有设备和设施保持有效状态。


    skills and experience required.

    1. Degree in Engineering (prefer Chemical, Mechanical, or Electrical/Automation) from accredited university(s). 获得认可大学的工程学位(化学、机械或电气/自动化优先)。

    1) BS with 15+ years of pharmaceutical, biotechnology/biologics, or food industry experience. 具有 15 年以上制药、生物技术/生物制品或食品行业工作经验的本科学 历。

    2) MS with 12+ years of pharmaceutical, biotechnology/biologics, or food industry experience.

    具有 12 年以上制药、生物技术/生物制品或食品行业经验的硕士学位。

    2. Strong verbal and written communication skills in English and Mandarin (Read, Write, Verbal). 良好的英语和普通话口头和书面沟通能力(读、写、说)。

    3. Basic knowledge and understanding of facility and utilities for biopharmaceutical processes. 对生物制药工艺的设施和公用事业有基本知识和了解。

    4. Sound knowledge of Good Engineering Practices (GEP) encompassing documentation and equipment selection for pharmaceutical facilities. 良好的工程实践(GEP)知识,包括制药设施的文档和设备选择。

    5. Sound Understanding of Good Manufacturing Practice (GMP). 对良好制造规范(GMP)的正确理解。

    6. Knowledge of maintenance of pharmaceutical utility systems (e.g. PW, WFI, Pure Steam, Compressed Air, and HVAC) and general building services (e.g. access control, boiler, waste neutralization, chillers, cooling towers, electrical power, emergency generators, compressed gas). 了解制药公用事业系统(例如 PW、WFI、纯蒸汽、压缩空气和 HVAC)和一般 建筑服务(例如门禁、锅炉、废物中和、冷却器、冷却塔、电力、应急发电 机、压缩气体)的维护知识。


    about the job.

    1. Site Safety and Environmental compliance 工地安全及符合环保规定

    1) Developing and maintaining a culture of safe working practices through personal leadership and establishing standard procedures for safety management. 通过个人领导和建立安全管理的标准程序,发展和维护安全工作文化。

    2) Enforcing a system for job safety assessments and issuing permits -towork including lock-out tag-out of energized and hazardous systems. Participation in site safety committee as required. 执行工作安全评估和发放工作许可证制度,包括封锁带电和危险系统。按 要求参加现场安全委员会。

    3) Coordinating applications for safety and environmental compliance permits and enforcing compliance with permit requirements. 协调安全和环境合规许可的申请,并强制执行许可要求。

    2. Design Management 设计管理

    1) Coordinating preparation of documented User Requirement Specifications. 协调编制文件化的用户需求规范。

    2) Management of specialist design consultants and liaison with vendors to design and specify systems. 管理专业设计顾问,并与供应商联络以设计和指定系统。

    3) Reviewing and approval of design packages for facilities and utilities. 审查和批准设施和公用设施的设计包。

    3. Engineering Maintenance工程维修

    1) Managing core site utilities to support continuous operation. 管理核心站点公用事业以支持持续运营。

    2) Preparing and managing the schedule of preventative maintenance and calibration activities for the site. Priority being core manufacturing facility and utilities and coordination with Production and QC departments. 准备和管理现场预防性维护和校准活动的时间表。优先考虑核心制造设施 和公用事业,并与生产和质量控制部门协调。

    3) Managing timely response to break-down events. 管理对故障事件的及时响应。

    4) 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,确保公用事业公司可在 24 小时内纠正已预见的机 械故障。

    5) Managing the security and access control for the site including induction and certification of contractors. 管理现场的安全和访问控制,包括承包商的入职和认证。

    6) Preparing and managing the programmed maintenance plan for the site covering cleaning and renovation of buildings and grounds to keep them in a high standard. 编制和管理现场的程序化维护计划,包括建筑物和地面的清洁和翻新,以 保持高标准。

    7) Contributing to investigation of quality investigations related to performance of facility and equipment. 协助调查与设施和设备性能相关的质量调查。

    4. Validation验证

    1) Support and assist in establishing and maintaining the system of testing for facilities, utilities, and equipment based on the CBL Biotech corporate standards. 支持并协助建立和维护基于 CBL 生物技术公司标准的设施和设备测试系统。

    2) Support and assist in the preparation of validation of equipment, facilities, and utilities. 支持和协助准备设备和公用设施的验证。

    3) Support and assist in coordinating execution of testing with vendors and CBL personnel. 支持并协助与供应商和 CBL 人员协调测试的执行。

    4) Ensuring the Company’s GMP utilities systems are maintained in a validated state. 确保 GxP 运营中使用的所有设备和设施保持有效状态。


    skills and experience required.

    1. Degree in Engineering (prefer Chemical, Mechanical, or Electrical/Automation) from accredited university(s). 获得认可大学的工程学位(化学、机械或电气/自动化优先)。

    1) BS with 15+ years of pharmaceutical, biotechnology/biologics, or food industry experience. 具有 15 年以上制药、生物技术/生物制品或食品行业工作经验的本科学 历。

    2) MS with 12+ years of pharmaceutical, biotechnology/biologics, or food industry experience.

    具有 12 年以上制药、生物技术/生物制品或食品行业经验的硕士学位。

    2. Strong verbal and written communication skills in English and Mandarin (Read, Write, Verbal). 良好的英语和普通话口头和书面沟通能力(读、写、说)。

    3. Basic knowledge and understanding of facility and utilities for biopharmaceutical processes. 对生物制药工艺的设施和公用事业有基本知识和了解。

    4. Sound knowledge of Good Engineering Practices (GEP) encompassing documentation and equipment selection for pharmaceutical facilities. 良好的工程实践(GEP)知识,包括制药设施的文档和设备选择。

    5. Sound Understanding of Good Manufacturing Practice (GMP). 对良好制造规范(GMP)的正确理解。

    6. Knowledge of maintenance of pharmaceutical utility systems (e.g. PW, WFI, Pure Steam, Compressed Air, and HVAC) and general building services (e.g. access control, boiler, waste neutralization, chillers, cooling towers, electrical power, emergency generators, compressed gas). 了解制药公用事业系统(例如 PW、WFI、纯蒸汽、压缩空气和 HVAC)和一般 建筑服务(例如门禁、锅炉、废物中和、冷却器、冷却塔、电力、应急发电 机、压缩气体)的维护知识。