Computer System Validation Engineer

About the RoleWe are seeking a motivated and detail-oriented Computer System Validation (CSV) Engineer to join our team in New Jersey. This full-time opportunity is ideal for recent graduates and early-career professionals with 0–3 years of experience who are looking to build a career in the pharmaceutical, biotechnology, and medical device industries. The successful candidate will support computerized system validation activities, ensuring compliance with FDA regulations, GxP requirements, and industry best practices while working closely with Quality, IT, Engineering, and Manufacturing teams.ResponsibilitiesAssist in the execution of Computer System Validation (CSV) activities for GxP-regulated systems.Develop and review validation documentation, including Validation Plans, Risk Assessments, IQ/OQ/PQ protocols, Traceability Matrices, and Validation Summary Reports.Support validation testing for laboratory, manufacturing, and quality systems.Participate in change control, deviation investigations, CAPA activities, and periodic reviews.Collaborate with Quality Assurance, IT, Engineering, and Manufacturing teams to ensure regulatory compliance.Maintain validation records and support audit and inspection readiness.Assist with system implementations, upgrades, and lifecycle management activities.QualificationsBachelor's degree in Engineering, Computer Science, Information Technology, Life Sciences, Biotechnology, or a related field.0–3 years of experience in Computer System Validation (CSV), Validation, Quality Assurance, IT, Engineering, Pharmaceutical, Biotechnology, or Medical Device industries.Internship, co-op, academic project, or professional experience in a regulated environment is highly preferred.Basic understanding of FDA 21 CFR Part 11, GxP, Data Integrity, SDLC, and GAMP 5 principles.Strong analytical, problem-solving, communication, and technical writing skills.Ability to work effectively in a cross-functional team environment.Preferred SkillsExposure to systems such as LIMS, MES, SAP, Empower, DeltaV, TrackWise, Veeva, or similar regulated applications.Familiarity with validation lifecycle documentation and testing methodologies.Knowledge of pharmaceutical manufacturing, laboratory operations, or quality systems.