Job Responsibilities 岗位职责
1. Participate in continuous improvement of the engineering and validation related management documents and process, such as validation master plan, system validation plan, validation related SMP, maintenance plan, calibration plan, pest control plan and engineering related SMP.
参与工程及验证相关管理文件和流程的改进，如验证主计划，系统验证计划，验证相关SMP，维护计划，校准计划，虫害管理计划及工程相关SMP。
2. Supervise the execution of qualification and validation for the facilities, utilities, system, computerized system and APS. Ensure the qualification and validation meet GMP requirements.
监督完成厂房设施，公用设施，系统，计算机化系统和无菌工艺模拟等的确认和验证的执行，确保确认和验证符合GMP要求；
3. Supervise new equipment qualification activity, including URS, risk assessment, D/I/O/PQ and ensure the qualification meet GMP requirements.
监督新系统的确认工作，包括URS，风险评估，D/I/O/PQ，确保确认符合GMP要求；
4. Participate to handle the quality events (deviation/CAP/change control/OOS) about engineering and validation for the facilities, utilities, system, computerized system and APS.
参与处理工程及厂房设施，公用设施，系统，计算机化系统和无菌工艺模拟等的质量事件（偏差/CAPA/变更/OOS）；
5. Complete facility and utility inspections regularly
定期完成公用设施巡检；
6. Participate in the internal and external audit.
参与内外审计；
7. Participate in Computerized System Validation work in collaboration with Subject Matter Experts.
与主题专家合作，参与计算机化系统验证工作；
8. Participate in the engineering and qualification work in new project.
参与新项目的工程及确认工作。
Qualification 任职资格
1. Bachelor degree and above or equivalent.
本科及以上或同等学历。
2. A minimum of 2 years of experience in validation within pharmaceutical or medical device industries or at least 3 years of pharmaceutical industry experience without formal qualifications experience.
具备至少三年制药或医疗器械行业的验证经验，或无验证经验但有至少五年制药行业经验。
3. Understand validation and qualification process defined in cGMP, regulation and other guideline such as ISPE commissioning and qualification.
理解cGMP，法规和其他指南中定义的验证和确认流程，如ISPE调试和确认；
4. Understand the operation principle of critical systems (e.g. sterilizers, isolators, PW, WFI, Pure Steam, Compressed Gasses, HVAC, filling line).
理解关键系统的运行原理（灭菌器，隔离器，纯化水系统，注射用水系统，纯蒸汽系统，压缩空气系统，HVAC，灌装线）；
5. Basic knowledge of Good Engineering Practices encompassing system design, factory testing, and commissioning.
具有基本的工程实践知识，包括系统设计、工厂测试和调试；
6. Proficient in common Microsoft office and other working software.
精通微软office和其他工作软件
7. Basic English reading and writing skills.
基本的英语读写能力。