CSV Validation Specialist
2 giorni fa
We are a 100% employee-owned company established in 1996, with over 700 people worldwide. Our mission is to provide commissioning, qualification, validation, start-up, project management, and other consulting services associated with operational readiness to FDA regulated and other mission-critical industries.
We put our clients' interests first and do not stop until it is right. As owners of CAI, we are committed to living our Foundational Principles, both professionally and personally: We act with integrity. We serve each other. We serve society. We work for our future.
Job DescriptionThe Computer Systems Validation (CSV) Engineer will develop and execute protocols and test scripts, identify gaps, and consult on and direct plans for resolution. 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 ideal candidate will have a BS in a Computer Science or Engineering field or equivalent experience. They will have 2-7 years' experience with Computer systems validation and 2 years' experience working in a GMP environment. Experience in Data Integrity with GAMP and 483 compliance, consent decree experience, deep 21CFR Part 11 experience is highly desired.
We use all major systems, including Rockwell, GE, Emerson, ABB, Werum, Siemens, Honeywell, and their associated platforms. The successful candidate will have excellent oral and written communication skills in English and be able to travel domestically and internationally as required.
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