南京招聘

Title: PD Engineer

Department: PDMS

Location: Xi'an Plant

Position Purpose

Guided by J&J, XJP new product development guidelines, and aligned with company strategic objectives under the leadership of Senior NPI Manager, the holder of this position shall implement new product introduction plan of related products, ensuring quality of new products, carry out pilot batch for manufacturing preparation purpose and product investigation to ensure timely & smooth introduction of new products, and implement process validation and cleaning validation plan of related products, ensuring quality of products.

Responsibility

1. Develop pharmaceutical process for specific new product, design and execute the manufacturing process on pilot batches, then realize it on commercial production scale.

2. Take a part of analytical development works for specific new product, draft specifications and methods for new excipients and finished-product, as well as other analytical development files, such as protocol and test records.

3. Make detailed action plans for specific product transfer and carry out the plans. For specific project, manages and supervises all subordinates and coordinate Xian Plant and PDMS about PDMS project and trouble shooting for technical issue. And ensure the timely completion of all transfer phases.

4. Prepare registration files for related product from PD or AD aspect.

5. Clinical trial sample preparation for specific product.

6. Draft and revised related protocol and report for process development, as well as process validation and cleaning validation on industrial scale. Responsible to establish the commercial Product BOM and Routing; Carry out process validation and cleaning validation on master validation plan; trouble shooting for related technical issue.

7. Know all position-related requirements for environmental, safety and industry hygiene, and comply with all these requirements.

Requirements & Qualifications

· Bachelor or above degree on pharmacy, chemistry, biochemistry and other related majors;

· Good knowledge on pharmacy, GMP requirements & trends of local & international regulatory & statutory environment, production & quality processes;

· Have analytical development ability and have experiences on this area, manipulation skill to analytical instrument;

· Understanding of equipment, quality management, manipulation skill to pharmaceutical equipment and instrument;

· Fluent English in speaking and writing and good skill in Office software operation.

公司简介(中文) 恢复为 “成立于1985年的西安杨森制药有限公司（“西安杨森”）是中国***的合资制药企业之一，也是中国改革开放以来进入中国的最早一批制药公司之一，其总部位于北京的中央商业区。西安杨森是强生公司的一员。从创立之初，西安杨森就致力于引进和生产许多创新产品和高质量产品。西安杨森一直致力于投资未来，计划增加在生物制品、心脏病学、风湿病学和泌尿科学领域的新系列产品。西安杨森致力于利用这些新药改善中国患者的医疗保健状况。

本着公司信条和关爱精神，西安杨森一直是活跃的企业公民，在医药、公共卫生、药物研发领域和企业社会责任方面从事了五十多项合作项目。例如，西安杨森与中国卫生部国际卫生交流与合作中心合作创立了“吴阶平医学研究奖和保罗•杨森药学研究奖”，旨在鼓励医药学领域的工作者不断创新。在过去的17年中，共计305名杰出医药学工作者在45个专业领域获得了该奖项，他们在科研领域做出了大量有价值的创新。 此外，西安杨森也被誉为培养制药行业人才的摇篮。1999年，西安杨森被财富杂志（中文版）评选为“中国最受敬仰的十大外资企业之一”。2005年，西安杨森被中国中央电视台评选为“***雇主”，并且分别在2008年、2009年和2010年获得了“中国大学生***雇主奖”。

目前西安杨森所有的招聘信息仅通过前程无忧，智联招聘和猎聘网进行发布，任何在非上述三家招聘网站看到的信息均非西安杨森正式发布。为避免对您的合法权益造成伤害，请务必通过正规渠道投递简历。

2013年，强生在西安高新区投资兴建强生全球供应链先进的生产基地，该项目建设目前已正式启动。新生产基地占地267,000平方米，将取代西安杨森在西安新城区现有的生产基地，成为强生供应链在亚洲的创新枢纽，从而更好地满足中国和其他新兴市场不断增长的需求。新的生产基地将采用世界***的制造技术和先进的质量体系，并引进集电子批号记录和数据存储于一身的全自动化配方生产操作系统以及先进的德国进口生产工艺设备。