Computer System Validation Specialist

Your role: We have an exciting opportunity as a Computer Systems Validation (CSV) Specialist within our Livingston site. You will lead Computer Systems Validation (CSV) across the site and support the execution of the Validation Master Plan. You will ensure compliance with regulatory requirements (21 CFR parts 11, 211, 600, ISO 9001, ISO 13485) and provide guidance on validation issues. Participate in investigations for failures, CAPA, and continuous improvement initiatives while maintaining and updating validation procedures. Stay informed on the latest regulatory requirements and support the IT department in Software and Hardware Validation compliance. Act as a subject matter expert (SME) for GxP systems, driving compliance strategies and managing GxP system life cycle activities, including change management and system integration projects. Who you are: Bachelor’s/Undergraduate Degree in a quality or science-related discipline (chemistry, biology, or medical technology preferred). Significant amount of experience in Computer Systems Validation. Expertise in GMP, FDA regulations, SOP development, and understanding of Validation and Data Integrity Principles. Strong analytical and problem-solving skills, with the ability to present results effectively. Proficient in Microsoft Word, Excel, and PowerPoint. Excellent written and verbal communication skills, capable of collaborating at all organizational levels. Ability to work well in a team, taking accountability for actions and contributing to team objectives.

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