CSV Engineer

Computer System Validation

Keywords – CSV, Computer System Validation, End to end validation, CSA, Computer System Assurance Roles and Responsibilities

Roles and Responsibilities

• Works on PST time zone
• Background and experience in AGILE SAFE methodology
• Experience in the Pharmaceutical, biotechnology, or medical device industry
• 2+ years' experience with System Development Lifecyle
• 7+ years' experience in Computer System Validation (Based on the role selected)
• Experience in FDA and/or Global regulated environment with good understanding of GxP standards and Risk based validation.
• Knowledge of FDA guidance's and industry standards (i.e., GAMP)
• Experience in writing and executing documentation for all aspects of the validation deliverables (etc. Requirements, Compliance/validation Plans, test protocols, Test Summary reports and Compliance/Validation Reports
• Experience in reviewing system test and user acceptance test scripts, Traceability matrix and Design Specs.
• Experience in QA Methodologies, designing, reviewing and approving Test Plans, systems and UAT test scripts and Test procedures.
• Strong verbal and written communication skills.
• Ability to work as a team player, lead a team or accomplish tasks without supervision.
• Ability to work with remote teams and support several changes/projects simultaneously.
• Ability to provide Validation guidance, timely reviews, and escalations to TQ management.