CSV Engineer

Overview CAI is a professional services company established in 1996 that has grown year over year to nearly 800 people worldwide. For Life Sciences and Mission Critical industries that need to deliver critical solutions in high-stakes environments, we provide accelerated operational readiness and unparalleled performance at the highest standard through our rigorous approach, field tested processes, and elite expertise developed over 30 years. Our approach is simple because our Purpose informs everything we do: We exist to be the trusted solution for our clients as they strive to build a better working world and improve the human experience. At 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 We believe in a relentless dedication to excellence, pushing boundaries and surpassing expectations. From the beginning, we’ve challenged ourselves to do what others wouldn’t. Not just setting industry standards, but redefining them entirely. We are bold in our thinking and creative in our approach. We operate at the intersection of wisdom and technology and thrive when they come together with humanity. For us, operational readiness isn’t simply a goal. It’s a way of life. Because tomorrow demands to be at the forefront of today. We do this through tireless effort, precision, efficiency and an unwavering belief that there is always room for advancement. We’re not interested in how it used to be done. We’re obsessed with how it will be done. Key Responsibilities Major Area 1 The 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. Position Requirements BS in a Computer Science or Engineering field or equivalent experience 2-7 Years’ Experience With Computer Systems Validation 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 Experience in biotech and pharma is preferred over medical device Experience with MES, Delta V, PI is a plus. We use all major systems as we serve a multitude of clients. Rockwell, GE, Emerson, ABB, Werum, Siemens, Honeywell and their associated platforms, PAS-X, Syncade, FactoryTalk, PharmaSuite, Control Logix, PLM, Simatic, iFix, Wonderware, Siemens, etc. Other Requirements: Excellent oral and written communication skills in English; Fluent in English Able To Travel Domestically And Internationally As Required DISPONIBILITA\' A FARE TRASFERTE SIA ITALIA CHE ESTERO La selezione rispetta il principio delle pari opportunità (l. 903/77) Job Details Seniority level: Not Applicable Employment type: Full-time Job function: Engineering and Information Technology Industries: Pharmaceutical Manufacturing #J-18808-Ljbffr