CSV Engineer

7 hours ago

Dublin, Ireland Cognizant Technology Solutions Ireland Full time

Cognizant is a world leader in delivering digital transformation solutions to Life Sciences. Through our knowledge and expertise in Automation, MES & Digital, we deliver stable manufacturing systems that are optimized to improve operational efficiencies, whilst maintaining compliance. Our specialist engineering teams have the aptitude to deliver and support Pharma 4.0 architectures and solutions covering all IT, OT and IoT applications, infrastructures and services. Operating across 5 continents and with over 300.000 skilled employees, Cognizant partners with the leading Life Sciences companies globally to provide performance improvements, reduced costs and improve time to market. We are your single end to end partner for consultancy, design implementation, optimization and support for all applications in the Pharmaceutical and Biotechnology Manufacturing stack. We're looking for dedicated, innovative and driven talent to join our expanding team. Experience/Attributes: Junior CSV Engineer - 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. Responsibilities BS in a Computer Science or Engineering field or equivalent experience 1-3 years experience with Computer systems validation 1 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 a plus 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. Excellent oral and written communication skills in English/Fluent in English Skills: Validation 21CFR

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