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 up when needed Support inspection preparation
• Knowledge of SOX, It security and infrastructure would be advantageous
• Understanding of modern and risk based validation executions.
• Knowledge of underlying infrastructure requirements supporting GxP systems a plus.
• 5+ years working in CSV or Quality role supporting computerized systems.
• Background in Life sciences and/or Pharma/Biotech industrie