Senior Commissioning and Qualification Engineer
Shanghai / China / Full Time
The Commissioning and Qualification Engineer at Commissioning Agents, Inc. develops the documentation to support C&Q. This person is responsible for protocol execution, field verification and generation of summary reports at the client site. The Commissioning and Qualification Engineer is critical in the company’s continued success and growth by providing the services to our clients that are key to our business.
Commissioning Agents, Inc. (CAI) is a rapidly expanding professional services organization headquartered in the United States with offices in Singapore, Malaysia, South Korea, Australia, China, Ireland and Puerto Rico. We work in the pharmaceutical, biotechnology, medical device, nutritional and building commissioning industries to provide industry best practices to our clients. Check us out at www.commissioningagents.com.
The successful Commissioning and Qualification Engineer must have:
· Bachelor degree or higher in Chemical, Mechanical, Biotech, Pharmaceutics or Pharma Engineering.
· Minimum 5 years of experience in commissioning and qualification in the pharmaceutical industry.
· Willing to travel.
· Ability to generate commissioning and qualification protocols for multiple types of compounding equipment, integrated filling machines, closed stopper processing, clean utility equipment and other GMP utility, HVAC, Facility, Process Manufacture systems.
· Ability to conduct field inspections including piping and equipment walk downs, operational startup and troubleshooting.
· Subject matter expert and experience in either biotech, aseptic fill finish, OSD or clean utilities (WFI, clean steam, PW, CDA, Nitrogen, CIP, etc)
Other requirement:
l Good Knowledge of EU / PICS / FDA GMP
l Be familiar with Microsoft software for document handling such as Word, Excel, Power Point, Visio, Project etc.
l Familiar with Auto CAD for drawing and reviewing.
l Good at English for reading, speaking, writing. Can write English technical documents with English.
l Team worker and keep learner.
l Easy to communicate and willing share.
In return for your skills and knowledge, CAI offers a wide range of benefits including:
· Medical, dental, disability, company paid life insurance and more
· Paid time off
· Continuing education (internal and external)
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