Job Description

About CAI CAI is a rapidly expanding professional services organization headquartered in the United States with offices in Singapore and China. We work in the pharmaceutical, biotechnology, medical device, nutritional and building commissioning industries including data centers to provide industry best practices to our clients. Check us out at www.cagents.com

The role: The CSV engineer has to assess and approve of alternate paths, step-by-step operator procedures, dispense specs, and so on . The validation process must enforce the security and compliance of an MES. Laboratory data capture devices.

Responsibilities:

• Performing commissioning and qualification services for various industries focusing on pharmaceutical and biotechnology; and providing consulting and technical services related to compliance with global current good manufacturing practices and technical expertise on all activities related to computer systems validation.
• Develop strategy for the validation of computer systems ensuring compliance to required regulatory requirements.
• Execution of IQ, OQ and PQ protocols
• Development of commissioning and qualification plans, risk assessments including SLIA and PFMEAs
• Ability to conduct field inspections including piping and equipment walk downs, operational startup and troubleshooting
• Other duties may be directed or established by the Vice President or Board of Directors of CAI Singapore from time to time.

• Degree in Engineering or Science discipline
• Minimum 5 years of experience in Pharmaceutical Industry
• Proven track record in promoting safety practices in related role
• Demonstrated proficiency of written and verbal communication skills (including technical writing and presentations) with ability to communicate and collaborate effectively with technical and senior management staff
• Independent individual and yet a strong team player
• Ability to interpret and operate within defined schedules managing available resources to achieve project milestones
• Experienced in developing automation protocols
• Good knowledge of cGMP, GAMP, GDP guidelines
• Knowledge of risk-based assessment