PWe are seeking CSV Engineers with 2-5 years' experience and 2 years' experience in GMP environment. /ppAbout CAI /ppCAI 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. /ppMeeting a Higher Standard /ppOur 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. /ppAs owners of CAI, we are committed to living our Foundational Principles, both professionally and personally: /ppWe act with integrity. /ppWe serve each other. /ppWe serve society. /ppWe work for our future. /ppWith 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. /ppCAI agents will be exposed to cutting edge technologies in the advanced medicine space. You will have an opportunity to work with recognized subject matter experts allowing YOU to be a key player in bringing lifesaving therapies to market. As part of our company culture, we invest in YOUR future, and commit to hands on certifications as well as professional training. Our collaborative culture ensures that our customers benefit from exemplary work across our entire range of professional services. /ppPosition Description: /ppThe 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. /ppPosition Requirements: /ppBS in a Computer Science or Engineering field or equivalent experience /pp2-7 years’ experience with Computer systems validation /pp2 years’ experience working in a GMP environment /ppExperience in Data Integrity with GAMP and 483, compliance, consent decree experience, deep 21CFR Part 11 experience is highly desired /ppExperience in biotech and pharma is preferred over medical device /ppExperience 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. /ppOther Requirements: /ppExcellent oral and written communication skills in English/Fluent in English /ppAble to travel domestically and internationally as required /ppuLa selezione rispetta il principio delle pari opportunità (l. 903/77) /u /pp#LI-AG1 /p /br /br #J-18808-Ljbffr