負責從設計到運營、放行、持續(xù)改進和退役的設施GMP設備和設施驗證生命周期的各個方面。
Responsible for all aspects of the Facility GMP equipment and facility validation lifecycle from design through operation, release, continuous improvement and retirement.
?負責廠房GMP設備/公用設施(例如純化水系統(tǒng)，壓縮空氣系統(tǒng)，環(huán)境監(jiān)視系統(tǒng))和受控工作環(huán)境(例如，潔凈室，倉庫)的調試與驗證工作
Responsible for commissioning and qualification of Facility GMP equipment/utilities (e.g. Purified Water System, Compressed Air System, Environment Monitoring System) and Control Work Environment (e.g. Clean Room, Warehouse)
?負責準備驗證文件，包括但不限于驗證草案、風險評估、定期審查。
Responsible for preparation of validation documentation such as but not limited to qualification protocols, risk assessments, periodic reviews.
?起草，審閱和批準設備驗證所需的技術文件
Author, review and approve technical documents needed for qualification of equipment
?負責日常運營的廠房蟲害防治規(guī)程，管理蟲害供應商，確保cGMP法規(guī)符合性。
Responsible for routine Pest Control procedure, vendor management and ensure cGMP regulatory compliance.
?負責日常運營的廠房設施儀表的校驗規(guī)程，管理校驗供應商，確保cGMP法規(guī)符合性。
Responsible for routine Facility Instrument Calibration procedure, vendor management and ensure cGMP regulatory compliance.
?確保新/改進廠房設施設備或系統(tǒng)經過正確的調試/驗證后交付投入運營
Ensures new/improvement facility equipment/system is appropriately commissioned/qualified and then handover for operational use.
?管理廠房設施工程團隊內部的培訓，受控文件和圖紙的版本，變更控制，良好文檔實踐等
Provide governance and management for training, controlled document and drawings, change control, GDP within Facility team
?支持廠房設施年度預算管理包括成本節(jié)約項目，監(jiān)視季度花費的準確性，確保公用設施和設備系統(tǒng)經濟運營
Support Facility Annual Operation Cost Plan including cost VIP projects, monitor quarterly cost expense accuracy, ensure Lean operation
?與跨職能團隊合作，支持卓越運營，支持實現所有現場目標
Collaborate with cross-functional team to support operational excellence and support achievement of all site objectives
?領導項目期間與GMP相關設備、設施和公用事業(yè)系統(tǒng)的調試與驗證等工作。

Leads the C&Q activities associated with GMP related equipment, facility and utility systems during project phase.
?參與所有中國藥監(jiān)和內部對工廠的檢查與審計
Participates in all China GMP and internal audits of the manufacturing facilities
?保持質量標準，以滿足GMP要求以及公司內部關于設備和系統(tǒng)的政策
Maintains quality standards to meet GMP requirements and internal company policies with respect to equipment and systems.

要求：

1. 專業(yè)知識Specific knowledge
?五年以上設施驗證工作經驗 Minimum 5 years experience of validation for Facility system
?在潔凈空調，潔凈室，潔凈公用設施系統(tǒng)方面擁有良好的專業(yè)知識 Good knowledge expertise in HVAC, Clean Room and Clean Utility.
?熟悉GMP，熟悉質量控制流 Be familiar with GMP and quality control processes
?熟悉設備驗證標準、方法等 Be familiar with Equipment Qualification standard and methodologies
?熟練使用微軟辦公工具處理文檔(Word, Excel) Be familiar with Document handling using Microsoft (Word, Excel)

2. 個人（領導力）技能Personal and interpersonal skills / Leadership skills
?善于在不同組織間相互溝通和影響的能力 Good at interacting within different functions of the organization.
?關注于客戶和業(yè)務Focus on costumer and business
?有良好的團隊精神Good Team player
?誠實正直 Integrity

3. 個人態(tài)度和心態(tài)Personal attitude and mindset
?以創(chuàng)新和改變?yōu)轵寗?，保證競爭力Drives for innovation and change to ensure competitiveness
?樂觀進取的心態(tài)，能夠在拔高的目標和時限要求下敏捷，靈活性工作Can-do mentality, agility & flexibility able to work with stretched goals and deadlines
?愿意將團隊的目標放在第一位并與團隊其他人一起朝著目標努力Willing to place the goals of the team first and work with others towards these goals
?對相關專業(yè)活動有高度責任感Showing a high sense of responsibility regarding professional activities

4. 良好的醫(yī)療器械生產規(guī)范 Good Manufacturing Practice (GMP)
?堅持遵守GMP的程序Adhere to applicable GMP and procedures
?報告事件和偏差Report events and deviations.

5. 安全，健康和環(huán)境績效Safety, Health and Environment Performance
?堅持遵守EHS的程序Adhere to applicable EH&S and procedures
?報告事故，未遂事件及偏差Reporting of accidents, near miss and deviations
?配合和建議方案提高EHS程序Cooperate on and suggest solutions to improve EH&S
?當看到違反EHS規(guī)則的行為要及時制止，做出適當的行動。Act when violation of EH&S rules is observed and stimulate appropriate behavior