CSV Specialist

The CSV Specialist supports validation of computerized systems in a regulated GxP environment. The role is responsible for developing and executing validation documentation, reviewing testing and UAT activities, applying risk-based validation methodologies, and ensuring systems comply with FDA and global regulatory requirements.

• Min 5 years of CSV experience.
• experience supporting validation of GxP GEN AI based solutions is a major plus
• experience supporting mergers/acquisitions/divestitures is a major plus
• Experience in the Pharmaceutical, biotechnology, or medical device industry
• Experience in FDA and/or Global regulated environment with good understanding of GxP standards and Risk based validation.
• 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, System/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.
• Bachelor's degree in Computer Science, Information Technology, Computer Engineering, Information Systems.
• Lead and support Computer System Validation (CSV) activities.
• Develop Requirements, Validation Plans, Test Protocols, Test Summary Reports, and Validation Reports.
• Review System Test and UAT scripts.
• Review Traceability Matrices and Design Specifications.
• Design, review, and approve validation Test Plans and procedures.
• Apply GxP and risk-based validation methodologies.
• Provide validation guidance and QA support to project teams.
• Support multiple projects and remote teams simultaneously.
• Provide timely validation reviews and escalate issues to management.
• Support validation of GxP GenAI-based solutions.
• Support validation activities related to mergers, acquisitions, and divestitures.