Job Responsibilities/工作職責
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:
全職運營和維護，負責CBL工廠在中國武漢的工藝設備、公用設施和設備。該職能負責CBL-1的商業生產設施、非商業和開發實驗室和設施：

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.
通過個人領導和建立安全管理標準程序，發展和維護安全工作實踐的文化。

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.
遵循工作安全評估制度，發放工作許可證，包括帶電和危險系統的上鎖掛牌。零失時工傷。

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施設備和工藝生產設備保持在可靠、合格和有效的狀態。

3. Responsible for the management, maintenance and repair equipment. Cooperate with other function module engineers to carry out repair and calibration and maintenance.
負責管理和維護、維修設備。配合部門其它功能模塊的工程師執行維修、校準、保養事宜
4. Manage and supervise the maintenance and operation of contractors and suppliers.
管理和監督承包商和供應商的維護和操作。

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.
積極參與公司質量管理體系的開發和實施，負責設施設備的偏差、變更、CAPA的GMP文件處理。

6. Site Facility operation and maintenance function including:
現場設施運行和維護功能，包括：

1) Buildings Maintenance Service, Clean and maintain plant utilities and equipment.
樓宇維修服務，清潔和維護工廠公用設施設備。

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

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

7. Preparing standard operating procedures and associated records for management and execution of the maintenance program.
為維護計劃的管理和執行準備標準操作程序和相關記錄。

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.
大專或本科(機械或電氣優先)，至少3年制藥行業工作經驗，或至少5年醫療器械、醫療保健或食品行業工作經驗。

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.
熟悉工廠生產的工藝設備的維修、維護知識，例如，制劑灌裝設備、生物原液生產設備、QC實驗室設備、液氮冰箱設備等。

3. Basic knowledge and understanding of facility and utilities for biopharmaceutical processes.
對生物制藥流程的設備和設施有基本的知識和理解。

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

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

6. Sound Understanding of Good Manufacturing Practice (GMP)
充分理解良好的生產規范（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) .
了解制藥公用設施系統(如PW, WFI，純蒸汽，壓縮空氣和HVAC)和灌裝生產線（如隔離器、灌裝機）和原液生產設備（如生物反應器）、QC實驗室設備（如液氮冰箱、檢測儀器）等功能塊的維護知識，以及一般建筑系統(如門禁控制，鍋爐，廢物中和，冷水機，冷卻塔，電力，應急發電機，壓縮氣體)維護的實際經驗。