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Job Responsibilities/工作職責(zé)
Fulltime maintenance and engineering for the utilities and facilities of CBL facilities in Wuhan, China. This function is responsible for the CBL-1 commercial facilities, administrative, and Laboratories:
全職運(yùn)營(yíng)和維護(hù)，負(fù)責(zé)CBL工廠在中國(guó)武漢的工藝設(shè)備、公用設(shè)施和設(shè)備。該職能負(fù)責(zé)CBL-1的商業(yè)生產(chǎn)設(shè)施、非商業(yè)和開發(fā)實(shí)驗(yàn)室和設(shè)施：

1. Site Safety
工廠安全
1) Developing and maintaining a culture of safe working practices through personal leadership and establishing standard procedures for safety management.
通過(guò)個(gè)人領(lǐng)導(dǎo)和建立安全管理標(biāo)準(zhǔn)程序，發(fā)展和維護(hù)安全工作實(shí)踐的文化。

2) Following the system for job safety assessments and issuing permits-to-work including lock-out tag-out of energized and hazardous systems. Zero lost -time injuries.
遵循工作安全評(píng)估制度，發(fā)放工作許可證，包括帶電和危險(xiǎn)系統(tǒng)的上鎖掛牌。零失時(shí)工傷。

2. Ensure that the company's public facilities and process production equipment that directly affect the company are maintained in a reliable, qualified and effective state.
確保公司的直接影響公用設(shè)施設(shè)備和工藝生產(chǎn)設(shè)備保持在可靠、合格和有效的狀態(tài)。

3. Responsible for the management, maintenance and repair equipment. Cooperate with other function module engineers to carry out repair and calibration and maintenance.
負(fù)責(zé)管理和維護(hù)、維修設(shè)備。配合部門其它功能模塊的工程師執(zhí)行維修、校準(zhǔn)、保養(yǎng)事宜
4. Manage and supervise the maintenance and operation of contractors and suppliers.
管理和監(jiān)督承包商和供應(yīng)商的維護(hù)和操作。

5. Active participation in the development and implementation of the Company Quality Management System, and responsible for the GMP documentation handling of DEV, CR, CAPA for utilities and equipment.
積極參與公司質(zhì)量管理體系的開發(fā)和實(shí)施，負(fù)責(zé)設(shè)施設(shè)備的偏差、變更、CAPA的GMP文件處理。

6. Site Facility operation and maintenance function including:
現(xiàn)場(chǎng)設(shè)施運(yùn)行和維護(hù)功能，包括：

1) Buildings Maintenance Service, Clean and maintain plant utilities and equipment.
樓宇維修服務(wù)，清潔和維護(hù)工廠公用設(shè)施設(shè)備。

2) HVAC (Classified Cleanrooms and general areas), Water for Injection system, Purified water system.
HVAC（分類潔凈室和一般區(qū)域）、注射用水系統(tǒng)、純化水系統(tǒng)。

3) Breakdown repair and trouble-shooting of utility
公用工程的故障檢修，電力系統(tǒng)（包括應(yīng)急發(fā)電機(jī)）的應(yīng)急處理。

7. Preparing standard operating procedures and associated records for management and execution of the maintenance program.
為維護(hù)計(jì)劃的管理和執(zhí)行準(zhǔn)備標(biāo)準(zhǔn)操作程序和相關(guān)記錄。

8. Complying with cGMP and local GB requirements.
符合cGMP和本地GB要求。


Job Requirements/崗位要求
1. College degree or Bachelor degree (mechanical or electrical preferred) with at least 3 years working experience in pharmaceutical industry, or at least 5 years working experience in medical device, healthcare or food industry.
大?；虮究?機(jī)械或電氣優(yōu)先)，至少3年制藥行業(yè)工作經(jīng)驗(yàn)，或至少5年醫(yī)療器械、醫(yī)療保健或食品行業(yè)工作經(jīng)驗(yàn)。

2. Be familiar with the repair and maintenance knowledge of process equipment produced in the factory, such as fill finish equipment, biological stock production equipment, QC laboratory equipment, Liquid nitrogen refrigerator etc.
熟悉工廠生產(chǎn)的工藝設(shè)備的維修、維護(hù)知識(shí)，例如，制劑灌裝設(shè)備、生物原液生產(chǎn)設(shè)備、QC實(shí)驗(yàn)室設(shè)備、液氮冰箱設(shè)備等。

3. Basic knowledge and understanding of facility and utilities for biopharmaceutical processes.
對(duì)生物制藥流程的設(shè)備和設(shè)施有基本的知識(shí)和理解。

4. Strong verbal and written communication skills in English and Mandarin (Read, Write, Verbal).
較強(qiáng)的英語(yǔ)和普通話的口頭和書面溝通能力（讀、寫、說(shuō)）。

5. Sound knowledge of Good Engineering Practices (GEP) encompassing documentation and equipment selection for pharmaceutical facilities.
具備良好的工程實(shí)踐(GEP)知識(shí)，包括制藥設(shè)施的文件編制和設(shè)備選型。

6. Sound Understanding of Good Manufacturing Practice (GMP)
充分理解良好的生產(chǎn)規(guī)范（GMP）

7. Hands-on experience in maintenance of pharmaceutical utility system s (e.g. PW, WFI, Pure Steam , Compressed Air, and HVAC) and filling production line (such as isolator and filling machine), raw liquid production equipment (such as bioreactor), QC laboratory equipment (such as liquid nitrogen refrigerator and detection instrument) , and general building systems (e.g. access control, boiler, waste neutralization , chillers, cooling towers, electrical power , emergency generators, compressed gas) .
了解制藥公用設(shè)施系統(tǒng)(如PW, WFI，純蒸汽，壓縮空氣和HVAC)和灌裝生產(chǎn)線（如隔離器、灌裝機(jī)）和原液生產(chǎn)設(shè)備（如生物反應(yīng)器）、QC實(shí)驗(yàn)室設(shè)備（如液氮冰箱、檢測(cè)儀器）等功能塊的維護(hù)知識(shí)，以及一般建筑系統(tǒng)(如門禁控制，鍋爐，廢物中和，冷水機(jī)，冷卻塔，電力，應(yīng)急發(fā)電機(jī)，壓縮氣體)維護(hù)的實(shí)際經(jīng)驗(yàn)。