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Computer System Validation Engineer

Company: (CAI) Commissioning Agents, Inc.
Location: Elkton
Posted on: February 25, 2021

Job Description:

CAI is a 100% employee-owned company established in 1996, that has grown year over year to more than 500 people worldwide. We provide commissioning, qualification, validation, start-up, project management and other consulting services to FDA regulated and other mission critical industries. CAI is seeking motivated Computer System Validation (CSV) Engineers to support biotech and pharmaceutical projects across the country. These are full-time opportunities with 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. As consultants to the entire industry, our employee owners are driven by the challenge and constant diversity of assignments, while having the stability of a company that has never had a lay off. On any given day we could be responsible for a myriad of things involved in starting a facility, equipment or process up including protocol writing and execution, FAT's SAT's, walk downs and development of summary reports at the client site.-- To get to those diverse projects our people can experience heavy travel. Although some people rarely travel, it is the exception to the rule. It's not unusual for our employee owners to travel locally M-F to client sites. If the distance is greater, or spans more time zones, we sometimes travel to the site for 10 days then come back for 4. We don't want to spend our free time in airports or doing laundry to pack again, and we don't expect our employees to. The Computer Systems Validation (CSV) Engineer will develop and execute protocols and test scripts. 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. Requirements include:-- BS in a Computer Science or Engineering field or equivalent experience 2-8 years' experience with Computer systems validation 2 years' experience working in a GMP environment Experience with GAMP and 483, compliance, consent decree experience, deep 21CFR Part 11 experience is highly desired 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, FactoryLogix, PLM, Simatic, iFix, Wonderware, etc. 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.-- This job description is not all inclusive and you may be asked to do other duties. CAI will also consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of the FCO. CAI is proud to be an Equal Opportunity Employer.--

Keywords: (CAI) Commissioning Agents, Inc., Wilmington , Computer System Validation Engineer, IT / Software / Systems , Elkton, Delaware

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