The Computer Systems Validation (CSV) Engineer will develop and execute protocols and test scripts. This person is responsible for writing GxP computer validation and 21 CFR Part 11 related documentation such as assessments, plans, URS, FRS, RTM, and summary reports. The Computer Systems Validation 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, 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.cagents.com.
· Bachelor of Engineering - Chemical or Mechanical Engineering
· 2-10 years of experience in managing the design and implementation of control software in the pharmaceutical, medical device or biotech industry.
· Experience with process controls equipment including PLCs, DCS, BMS and SCADA systems in a GMP environment
· Knowledge of GAMP5 and S88 and a comprehensive understanding of EU Annex 11 and 21 CFR 11.
· Experience in MEP / MES / LIMS
· Thorough understanding of industry standards and best practices for computer system validation such as ASTME2500
· Willing to travel up to 100% of the time
· Excellent oral and written communication skills in English/Fluent in English.
· Singapore or Permanent residents may apply.
In return for your skills and knowledge, CAI offers a wide range of benefits including:
· Full time permanent position with a very competitive package
· ESOP, medical, company paid life insurance and more
· Paid time off
· Continuing education (internal and external)