CSV Engineer(Tools Validation)

Title : CSV Engineer(Tools Validation)Location : Raritan NJ Duration :12 MOnths · Minimum 7 years of experience in CSV having exposure to at least one of the following: R&D, Manufacturing, Laboratory · Clear understanding of principle, procedures and governance of validation activities and IT controls · Working Knowledge of regulations: 21 CFR Part 11 / 210/ 211 and Annex 11 · Understanding of quality risk-management concepts (ICH Q9) · Experience in systems validation and quality frameworks · Perform quality review of relevant validation documentation pre and post execution for accuracy, completeness and ensures compliance with regulatory and client requirements. · Experience in executing change control and document management · Strong Knowledge of GAMP5 and Quality Systems · Experience on decommission, Archiving and Data Integrity (ALOCA+) · Experience in supporting Data Migrations from validation perspective · Ability to communicate and work independently with Technical teams · Adept with Agile and Waterfall methodology based software development and has prior experience in computer system validation using agile methodology · Prior experience in using of tools like ALM, Document Management system (EDMS), ServiceNow and JIRA · Tools Validation experienceAdded Advantage: if they have previously worked at JNJ