上海招聘

  SUMMARY OF ESSENTIAL FUNCTIONS:  

  

The validation specialist position effectively and efficiently manages all validation for equipment, facility and temperature-controlled units and IT system for CSS China, to provide overall validation services that are in accordance with Company requirements and governing agencies that are well documented. Apply extensive industry experience to troubleshoot and optimize facility equipment and all utilities. Work independently to identify and initiate projects for facility improvements with appreciable direction.

  

  

SPECIFIC DUTIES, ACTIVITIES AND RESPONSIBILITIES INCLUDE BUT ARE NOT LIMITED TO:

  

  

• Draft procedure and report of facility/equipment/instrument qualification.

• Assist the execution of facility/equipment/instrument qualification.

• Coordinate with Facility Department in terms of validation instrument calibration.

• Responsible for validation/qualification annual review, requalification, deviation, change control, investigation, CAPA, and/or the other GMP activities related to facility, equipment and cleaning. Able to write change controls, deviations and CAPAs in a logical and clear manner and follow up progress.

• Support in process/analytical method/cleaning validation coordinating with other related department/team.

• Prepare monthly/weekly summary report for facility/equipment/instrument qualification related activities.

• Communicate with and assist different group or department in a timely manner to fulfill the work assignment with efficiency.

• Conduct the work assignments in compliance with cGMP regulations whenever applicable.

  Position Requirements:

  Education or Equivalent:

                        

• BS degree in chemical, mechanical, electrical engineering or equivalent experience

  

  

Experience:

  

• Minimum 3 years’ experience in engineering/engineering management, preferably in a pharmaceutical/FDA-regulated work environment.

    

Knowledge / Skills Requirements:

  

• High level of attention to detail.

• Excellent documentation skills.

• Knowledge of facility engineering/design such as HVAC system, clean facility is a plus.

• Knowledge and experience in cGMP/FDA regulations. Experience in regulatory audits desired.

• Excellent verbal, written and interpersonal communication skills.

• Demonstrated ability to handle multiple complex tasks and make timely/appropriate decisions with respect to product quality, compliance and the customers.

• Strong math (statistical), root cause analysis and troubleshooting skills.

• A full complement of business computer literacy skills (e.g. word processing, spreadsheets, database software etc.)

• Demonstrated experience in handling and responding to customer complaints and inquiries.

• Demonstrated ability to read, write and speak clear English.

                    

  

Physical Requirements:

  

• Ability to stand for up to 8 hours per day

• May be exposed to inclement weather or be required to work in environments or under conditions that require the use of protective gear and/or awareness of personal safety and safety of others.

• Frequent sitting, standing, walking, climbing ladders/steps, reading of written documents and use of computer monitor screen, reaching with hands and arms, stooping, kneeling, crouching, talking, bending, grasping, listening.

• Occasional, walking up inclines and uneven terrain, writing, carrying.

• Frequent lifting and/or moving up to 50 pounds.

          

  

Business Environment:

  

• Fast-paced

• Performance driven

• Customer focused

• Collaborative and inclusive

  

Catalent Overview

We are a global leader in providing integrated services, superior drug delivery technologies and manufacturing solutions to help life science innovators develop and launch successful pharmaceuticals, biologics and consumer health products. We have built an advanced range of technologies and capabilities and are dedicated to enabling a better and faster customer journey from product development to patient.
With over 85 years of experience in the industry, Catalent supports our partners in introducing 200 new products and manufacturing over 70 billion doses each year. We became a publicly traded company (NYSE: CTLT) in 2014 and have grown to become a vibrant community of more than 11,000 employees supporting over 7000 products for over 1000 customers all around the world. At Catalent, we share a common goal, to put patients first and help people around the world live better and healthier lives.
Currently, Catalent has invested in two facilities in Shanghai, China, located in Waigaoqiao FTZ and Pudong Tangzhen, is near by China’s Zhangjiang Pharma Valley area. The two clinical supply centers will work together to provide a comprehensive range of clinical supply services to clients in China, Asia Pacific and around the world.

Catalent. More products. Better treatments. Reliably supplied.™

For more information please visit our website ****************


康泰伦特概览

我们是临床研发和给药技术的全球领导者，从药物研发，商业化生产到全球服务，我们的技术和服务贯穿于产品的整个生命周期，配方前期研究到生产供应的每一个阶段，我们都能提供完善的方案服务，助力提供更好的产品疗效，让每个人的生活更健康，更精彩。
康泰伦特拥有85年的行业服务经验，每年支持我们的合作伙伴推出200+新产品，超过700亿的年产量。康泰伦特是一家朝气蓬勃的公司于2014年上市并发展成为在全球拥有11,000名雇员，为全球1000多家客户提供7000多款产品。在康泰伦特我们的核心价值观是患者***，在全世界范围内，运用专业知识和先进技术和客户合作提高和改善患者生活。
目前，康泰伦特已在中国上海投资了两家临床供应中心，分别位于外高桥保税区和毗邻张江药谷的浦东唐镇，满足客户国内外临床试验的差异化需求。两家临床供应中心将共同协作为中国、亚太以及全球客户提供全面广泛的临床供应服务。

康泰伦特。更多的产品。更好的治疗。可靠地供应。™

获取更多信息请浏览公司官网 ****************