Position Description: The Computer Systems Validation (CSV) Engineer is responsible for writing GxP computer validation and 21 CFR Part 11 related documentation such as assessments, plans, URS, FRS, RTM, and summary reports. They will also develop and execute protocols and test scripts as required. Requirements include: Position Requirements: BS in Computer Science or Engineering or equivalent experience 3+ years experience with Computer Systems Validation Experience with GAMP, 483, compliance, and deep knowledge of 21 CFR Parts 210, 211, and 11 is preferred Experience in biotech and pharma is preferred over medical devices Experience with Rockwell PharmaSuite, Emerson Syncade, MES, Delta V, PI, and other major systems such as GE, ABB, Werum, Siemens, Honeywell, PAS-X, FactoryTalk, PharmaSuite, FactoryLogix, PLM, Simatic, iFix, Wonderware, etc., is a plus Familiarity with the S88/S95 batch control standard and Process Control Systems Familiarity with Data Integrity assessment and/or remediation experience Other Requirements: Excellent oral and written communication skills in English Ability to travel domestically and internationally as required Able to work (paid) overtime Able to work in the US without sponsorship now or in the future About CAI 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 consulting services for FDA-regulated and other mission-critical industries. Are You Ready? Our approach is to prioritize client interests, strive for excellence, and do whatever it takes to succeed. As employee-owners, we are committed to our Foundational Principles: acting with integrity, serving each other and society, and working for our future. We value teamwork, respect, and a Can-Do attitude, which have contributed to our growth. Benefits Our full-time positions offer competitive compensation and benefits, including up to 15% retirement contribution, 24 days PTO, 5 sick days, low-cost health insurance, support for professional development, and 70% long-term disability paid by the company.
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