Computer Systems Validation Engineer
Seattle, Washington / Pacific / Full Time
CAI is seeking motivated CSV Engineers to support biotech and pharmaceutical projects across the country. These are full-time opportunities with competitive compensation and benefits which include: Long Term Disability and Life Insurance provided by the company. Health insurance at very low cost to employee, 15 % retirement Contribution, 24 days PTO and 5 sick days per year, and support for continued professional education, with the ability to earn additional vacation based on completion of internal qualification programs.
CAI is a 100% employee-owned company providing CQV, start-up, project management and consulting services to FDA regulated and mission critical industries. CAI was established in 1996 and has steadily grown to be an industry leader with 500 employees worldwide.
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.
BS in a Computer Science or Engineering field or equivalent experience
4 years’ experience with Computer systems validation in the USA
2 years’ experience working in a GMP environment
Experience with GAMP is highly desired
Experience in biotech and pharma is preferred over medical device
Experience with MES, Delta V, PI is a plus
Excellent oral and written communication skills in English/Fluent in English
Able to travel domestically and internationally as required
Able to work (paid) overtime
Able to work in the US without sponsorship now or any time in the future.
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