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5-7年经验 -
本科 -
招若干人 -
11-14 发布
职位描述
职位描述： Overview:1. Your direct supervisor will be client Validation Manager or Project Manager; your direct subordinates will be Process Validation Engineer, Cleaning Validation Engineer, MFG Equipment Validation Engineer, Facility & Utilities Validation Engineer, HVAC Validation Engineer, CTUs Validation Engineer, CSV Engineer, Lab Instrument Validation Engineer.2. As a lead validation engineer, you must be able to organize & manage the execution of all kind of PQ activities for example EMPQ (Environment Monitoring), Media fill, Manufacturing Trial Run etc.3. As a lead validation engineer, you must be able to guide or execute the 4Q of any specified system by client which includes validation protocol/report generation, test execution etc. For example, CIP/COP system, Washer/Autoclave, Filling line etc.Responsibility:1. Manage validation & qualification activities through project lifecycle from engineering, procurement, construction & installation to commercial manufacturing covering various equipment/facilities/utilities/computer systems or cleaning/analytical methods/processes.2. Prepare Project Validation Master Plan, Qualification Execution Plan etc.3. Establish and maintain validation management & execution relevant SOP.4. Establish validation & qualification template for example URS, FMEA, xQP/xQR.5. Review/Approval system URS, FMEA, Validation Protocol, Plan, and Report.6. Support the activities of facility’s engineering, commissioning and review the related documentations for example Technical Specification, P&ID, datasheet, vendor documents etc.7. Lead and manage the validation execution of whole project. Ensure the facility & utility, HVAC, process equipment and computerized system are validated per VMP/QPP and in compliance with the requirement from EMEA, FDA and CFDA.8. Responsible for executions of Computerized System Validation, Method Validation, Shipping Validation, Cleaning Validation, and Process Validation.9. Review/approval deviation and change from validation perspective; Review and approve the validation internal deviation.10. To communicate with and assist different group or department in a timely manner to fulfill the work assignment of high quality and efficiency.Requirements:1. Bachelor degree or above, major in biological, pharmaceutical engineering or similar.2. At least 5 years of working experience in validation execution; familiar with the qualification of Facility, Equipment/instrument, and Utility; Familiar with Computerized System Validation, Method Validation, Shipping Validation, Cleaning Validation, and Process Validation.3. At least 5 years of working experience in Validation Management; familiar with relevant regulations and guidelines of validation for example ISPE, ASTM E2500.4. Excellent English skill in both written and oral is mandatory.5. Good skills in computer software for example MS office, MS project.6. Excellent communication, problem-solving, and organization skills, Attentive, careful, and meticulous, with strong team-work skills.7. Familiar with GxP, GAMP, ASTM, FDA, 21 CFR Part 11.8. Good training & coaching skill.9. Willing to travel. 职能类别： 质量管理/测试工程师(QA/QC工程师) 生物工程/生物制药 关键字： 验证 validation leader
联系方式
苏州
公司信息
渊资是医药、化工、食品行业里产品研发，工厂建设及运营管理方面的专业工程、技术服务组织。在产品研发领域，我们与客户一起致力于开发流程、实验项目与实验中心的标准化及国际化；帮助客户提高产品质量，加快研发速度，降低开发成本，从而为客户获得最大的经济效益。在工厂建设领域，我们提供从项目选址、可行性研究、设计、采购、施工到设备安装、调试、验证的全方位工程及项目管理服务。无论项目大小、改扩建、高低端、内外资，我们都确保客户的需求在平衡质量、成本及进度的前提下得到最大满足。在运营管理领域，我们既帮助客户创建新的体系，制定新的规则、计划、程序及流程；亦利用我们手里的创新工具对已有生产、质量、维护体系及物流系统进行诊断，评估，进而 帮助客户进行快速改进，从而全方位提升工厂的经营能力。咨询行业里从不缺乏高屋建瓴，点石成金的大师，但这并不是渊资所要探索的。渊资的追求在于应用自己手中所积累的经验，素材，在自己熟悉和擅长的领域里解决客户各类实实在在的工程、技术需求，并从而与客户共同发展。
