Computer System validation Specialist

Job Title: CSV (Computer System Validation) SpecialistLocation: Jersey City, NJJob Summary:We are seeking an experienced Computer System Validation (CSV) Specialist with expertise in Valgenesis to join our team in Jersey City, NJ. The ideal candidate will have 7 to 10 years of experience in CSV within the medical device, pharmaceutical, or life sciences industry. This role involves ensuring compliance with FDA, GxP, 21 CFR Part 11, and other regulatory standards while validating various computer systems used in GxP environments.Key Responsibilities:Develop and execute Computer System Validation (CSV) plans, protocols, and reports in compliance with regulatory requirements.Ensure validation activities align with GAMP 5, 21 CFR Part 11, EU Annex 11, and other industry standards.Conduct risk assessments and impact analysis for computerized systems.Prepare and maintain Validation Master Plans (VMP), User Requirement Specifications (URS), Functional Requirement Specifications (FRS), and Design Qualification (DQ) documents.Author and execute IQ, OQ, PQ (Installation, Operational, and Performance Qualification) protocols.Support system change management, deviation investigations, and CAPAs related to CSV activities.Collaborate with IT, Quality Assurance, and Regulatory Affairs teams to ensure validation requirements are met.Review vendor documentation and perform vendor audits when necessary.Maintain compliance with FDA, ISO, and other regulatory agency requirements for computerized systems.Provide guidance and training on CSV best practices and regulatory compliance.Required Skills & Qualifications:Bachelor's or Master's degree in Computer Science, Engineering, Life Sciences, or a related field.7 to 10 years of hands-on experience in Computer System Validation (CSV).Strong knowledge of FDA 21 CFR Part 11, GxP, GAMP 5, and regulatory guidelines.Experience validating ERP, LIMS, MES, QMS, TrackWise, and other GxP systems.Hands-on experience in writing and executing IQOQPQ protocols.Strong analytical, documentation, and problem-solving skills.Excellent communication and stakeholder management skills.Experience working in pharmaceutical, medical device, or biotech industries.Expertise in Valgenesis for system validation.Ability to work independently and collaboratively in a regulated environme

Created: 2025-02-15