Computer Systems Validation Specialist
6 days ago
We are seeking a highly skilled Computer Systems Validation Engineer to join our team at CAI. As a key member of our team, you will be responsible for developing and executing protocols and test scripts to ensure the validation of computer systems.
Key Responsibilities:- Develop and execute protocols and test scripts for computer system validation
- Write GxP computer validation and 21 CFR Part 11 related documentation
- Assess and plan for computer system validation
- Experience with GAMP and 483 compliance, consent decree, and 21 CFR Part 11
- Experience with MES, Delta V, PI, and other major systems
- BS in Computer Science or Engineering or equivalent experience
- 5+ years of experience in computer systems validation
- Excellent oral and written communication skills in English
- Able to travel domestically and internationally
- Able to work overtime and in the US without sponsorship
CAI is a 100% employee-owned company established in 1996 with over 700 employees worldwide. We provide commissioning, qualification, validation, start-up, project management, and other consulting services to FDA-regulated and other mission-critical industries.
We put our clients' interests first and do whatever it takes to get the job done right. Our employee-owners are committed to living our Foundational Principles, which include acting with integrity, serving each other, serving society, and working for our future.
Benefits:- Competitive compensation and benefits package
- Up to 15% retirement contribution
- 24 days PTO and 5 sick days per year
- Health insurance at extremely low cost to employee
- Financial support for professional education
- 70% long-term disability paid for by the company
We are an equal opportunity employer and proud to employ veterans and promote diversity and inclusion in our workplace. We pledge to operate in a way that is fair and equitable to all.
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