Position Description: The Computer Systems Validation (CSV) Engineeris 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 21CFR Part 210, 211 and 11 experience is preferred Experience in biotech and pharma is preferred over medical device 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. GE, ABB, Werum, Siemens, Honeywell and their associated platforms, 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 that has grown to more than 700 people worldwide. We provide commissioning, qualification, validation, start-up, project management and other consulting services associated with operational readiness to FDA regulated and other mission-critical industries. Are You Ready? Our approach is simple; we put the client’s interests first, we do not stop until it is right, and we will do whatever it takes to get there. 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. With employee ownership, one person’s success is everyone’s success; we work diligently to accomplish team goals. We place Team Before Self, demonstrate Respect for Others, and possess a Can-Do Attitude (our core values). That is how we have grown exponentially. Benefits Our full-time positions offer competitive compensation and benefits which include: 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 both internal and external professional education as well as 70% long term disability paid for by the company.
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