Baltimore, Maryland/Mid Atlantic/Full Time 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. Where required, they will be expected to develop and execute protocols and test scripts. Requirements include: Position Requirements: BS in a Computer Science or Engineering field or equivalent experience 3+ years experience with Computer systems validation Experience with GAMP and 483, compliance, deep 21 CFR Parts 210, 211, and 11 experience is preferred Experience in biotech and pharma is preferred over medical devices Experience with Rockwell PharmaSuite, Emerson Syncade, MES, Delta V, PI is a plus. We use all major systems as we serve a multitude of clients, including GE, ABB, Werum, Siemens, Honeywell, and their associated platforms like PAS-X, FactoryTalk, PharmaSuite, FactoryLogix, PLM, Simatic, iFix, Wonderware, etc. 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/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 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 other consulting services related to operational readiness for FDA regulated and other mission-critical industries. Are You Ready? Our approach is simple: we prioritize the client’s interests, strive for excellence, and do whatever it takes to succeed. As owners of CAI, we are committed to our Foundational Principles: Act with integrity Serve each other Serve society Work for our future With employee ownership, success is shared. We emphasize teamwork, respect, and a Can-Do Attitude, which has driven our growth. 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 coverage. Benefits Overview (Varies by Country): Comprehensive health insurance Paid time off ESOP/401K with 15% company contribution (US) 15% pension contribution (Europe and APAC) Company-paid life assurance and income protection Career and professional development opportunities #J-18808-Ljbffr Cagents
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