Computer Validation 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.Requirements Include BS in a Computer Science or Engineering field or equivalent experience Experience with Computer systems validation in the USA 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. Excellent oral and written communication skills in English/Fluent in English Develop IT SOP’s Forms for IT compliance CSV data management (transfer and exchange of data in clinical studies) data integrity It security CSV Awareness and in depth knowledge of CSV (GxP) especially clinical. Ability to work with business to complete new and retrospective System impact assessments. Update and manage system inventory Support CSV projects as back