The Commissioning and Qualification Engineer at CAI develops the documentation to support C&Q. This person is responsible for risk assessments, 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.
CAI is a rapidly expanding professional services organization headquartered in the United States with offices in Singapore, China, Ireland. 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.cagents.com .
The successful Senior Commissioning and Qualification Engineer must have:
· Bachelor of Engineering - Chemical Engineering
· Minimum 4-6 years of experience in commissioning and qualification in the pharmaceutical industry
· Ability to generate commissioning and qualification protocols for multiple types of compounding equipment, integrated filling machines, closed stopper processing and clean utility equipment
· Cycle Development for SIP and CIP
· Execution of IQ, OQ and PQ protocols
· Development of commissioning and qualification plans, risk assessments including SLIA and PFMEAs
· Familiar with FDA, EMEA and PICS regulatory requirements
· Ability to conduct field inspections including piping and equipment walk downs, operational startup and troubleshooting
· Willing to travel up to 100% of the time
· Excellent oral and written communication skills in English/Fluent in English.
· Project engineering experience.
· Singapore or Permanent residents may apply.