Senior Validation Engineer(Lab Equipment)
渊资工程技术(上海)有限公司
- 公司规模:少于50人
- 公司性质:民营公司
- 公司行业:制药/生物工程
职位信息
- 发布日期:2017-03-23
- 工作地点:苏州-工业园区
- 招聘人数:1人
- 工作经验:5-7年经验
- 学历要求:本科
- 职位月薪:1-2万/月
- 职位类别:生物工程/生物制药 质量管理/测试工程师(QA/QC工程师)
职位描述
职位描述:
Responsibilities: 1. Completing work assignments as specified by Validation Manager. 2. Providing timely updates to Validation Manager. 3. Adhering to proper site safety practices for example to equip with PPE when required. 4. Completing timesheets and expense reports in a timely manner. 5. Working in a biotech/pharmaceutical environment as a consultant to conduct all kind of qualification activities for Lab equipment. 6. Working closely with client's employees to solve all validation issues. 7. Learning new ideas, techniques and systems. 8. Keep client's proprietary information confidential. 9. Preparing validation protocols such as DQP, IQP, OQP and PQP for Lab Equipment. 10. Executing validation test such as DQ, IQ, OQ and PQ for Lab Equipment. 11. Calibrating thermocouples for temperature mapping studies. 12. Calculating and interpreting of collected data from validation studies. 13. Preparing validation report such as DQR, IQR, OQR and OQP for Lab Equipment. 14. Generating validation summary reports and help client to prepare SOPs. 15. Implement validation risk assessments when required. Requirements: 1. Diploma or degree qualification preferred B.S in Pharmaceutical, Medical, Chemical, or other Life Sciences degree. 2. Knowledge of GMP facilities and cGMP requirements. 3. A minimum of 5 to 10 years of GMP experience in a biotech or pharmaceutical QC lab environment, or the equivalent, is desired. 4. Familiar with lab equipment for example freezers, biosafety cabinet, autoclave, glassware washer, Lab PW, incubator, water bath, fume hood, HPLC etc. 5. Proficient in computer skills and MS Office applications. 6. Knowledge of control systems (PLC, Microprocessor etc.) is desired. 7. Knowledge of validation test instruments such as Kaye Validator is desired. 8. Excellent written and verbal communication skills in English. 9. A demonstrated ability to work well in a team environment. 10. Well presented.
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Responsibilities: 1. Completing work assignments as specified by Validation Manager. 2. Providing timely updates to Validation Manager. 3. Adhering to proper site safety practices for example to equip with PPE when required. 4. Completing timesheets and expense reports in a timely manner. 5. Working in a biotech/pharmaceutical environment as a consultant to conduct all kind of qualification activities for Lab equipment. 6. Working closely with client's employees to solve all validation issues. 7. Learning new ideas, techniques and systems. 8. Keep client's proprietary information confidential. 9. Preparing validation protocols such as DQP, IQP, OQP and PQP for Lab Equipment. 10. Executing validation test such as DQ, IQ, OQ and PQ for Lab Equipment. 11. Calibrating thermocouples for temperature mapping studies. 12. Calculating and interpreting of collected data from validation studies. 13. Preparing validation report such as DQR, IQR, OQR and OQP for Lab Equipment. 14. Generating validation summary reports and help client to prepare SOPs. 15. Implement validation risk assessments when required. Requirements: 1. Diploma or degree qualification preferred B.S in Pharmaceutical, Medical, Chemical, or other Life Sciences degree. 2. Knowledge of GMP facilities and cGMP requirements. 3. A minimum of 5 to 10 years of GMP experience in a biotech or pharmaceutical QC lab environment, or the equivalent, is desired. 4. Familiar with lab equipment for example freezers, biosafety cabinet, autoclave, glassware washer, Lab PW, incubator, water bath, fume hood, HPLC etc. 5. Proficient in computer skills and MS Office applications. 6. Knowledge of control systems (PLC, Microprocessor etc.) is desired. 7. Knowledge of validation test instruments such as Kaye Validator is desired. 8. Excellent written and verbal communication skills in English. 9. A demonstrated ability to work well in a team environment. 10. Well presented.
职能类别: 生物工程/生物制药 质量管理/测试工程师(QA/QC工程师)
公司介绍
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。
As a professional engineering & technology service provider for Pharmaceutical, Medical, Chemical and Food industry, YANZ services its clients in the aspects such as research and development of new products; engineering and construction of new factory; operations management of existing factory.
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***的经济效益。
In the field of new product research & development, YANZ accompanies its clients for the standardization & internationalization of development procedure, experimental program and experiment center. At the same time, YANZ help client maximum the economic benefits by improving product quality, accelerating development progress and reducing of development cost.
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***满足。
In the field of new factory engineering and construction, YANZ provides engineering and project management service for example project location alternatives, feasibility study, plant concept engineering, facilities detail engineering, procurement support, construction management, commissioning & qualification management etc. YANZ ensures all user requirements will be well implemented during execution no matter the project are big or small, greenfield or renovation, high or low end, foreign or local investment.
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。
In the field of existing factory operations management, YANZ help client to create new system and establish new regulation, schedule, procedure and process. Also, YANZ help client diagnose & assess its existing manufacturing, quality, maintenance and logistics management system by utilizing innovative tools, and to provide improvement solution subsequently.
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。
There’s never lack of high level masters on the consulting market who have farsightedness and can turn stone into gold, but this is not what YANZ looking for. Our target is to accompany with clients to solve all kinds of real engineering & technology issues based on accumulated experience in dedicated industries and to get YANZ developed accordingly.
公司官网:*********************
Website: *********************
As a professional engineering & technology service provider for Pharmaceutical, Medical, Chemical and Food industry, YANZ services its clients in the aspects such as research and development of new products; engineering and construction of new factory; operations management of existing factory.
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***的经济效益。
In the field of new product research & development, YANZ accompanies its clients for the standardization & internationalization of development procedure, experimental program and experiment center. At the same time, YANZ help client maximum the economic benefits by improving product quality, accelerating development progress and reducing of development cost.
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***满足。
In the field of new factory engineering and construction, YANZ provides engineering and project management service for example project location alternatives, feasibility study, plant concept engineering, facilities detail engineering, procurement support, construction management, commissioning & qualification management etc. YANZ ensures all user requirements will be well implemented during execution no matter the project are big or small, greenfield or renovation, high or low end, foreign or local investment.
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。
In the field of existing factory operations management, YANZ help client to create new system and establish new regulation, schedule, procedure and process. Also, YANZ help client diagnose & assess its existing manufacturing, quality, maintenance and logistics management system by utilizing innovative tools, and to provide improvement solution subsequently.
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。
There’s never lack of high level masters on the consulting market who have farsightedness and can turn stone into gold, but this is not what YANZ looking for. Our target is to accompany with clients to solve all kinds of real engineering & technology issues based on accumulated experience in dedicated industries and to get YANZ developed accordingly.
公司官网:*********************
Website: *********************
联系方式
- 公司地址:地址:span上海