Remote SAP CSV Consultant (Computer Systems Validation Expert)

Job DescriptionJob DescriptionContract Duration :3-6 MonthsCompensation :$40 / hour (Remote, W-2 or 1099)Location :Remote, This is a USA based position onlyAbout the RoleWe are seeking a CSV Consultant (Computer Systems Validation Expert) to support validation activities in regulated industries such medical devices, and biotechnology.The ideal candidate will be an experienced professional with a strong command of FDA 21 CFR Part 11 , GAMP 5 , and GxP requirements.In addition to have Validation experience in SAP and understand it from the superuser perspective.This role involves the full lifecycle of validation -- from planning and writing detailed validation protocols to executing tests, documenting outcomes, and ensuring systems maintain data integrity and regulatory compliance.Key ResponsibilitiesPlan, write, and review validation protocols and related documentation for computer systems.Draft and maintain test scripts , IQ / OQ / PQ protocols , and validation reports.Conduct and document testing activities to verify systems function as intended and meet all regulatory and business requirements.Ensure data integrity and adherence to FDA 21 CFR Part 11 , GAMP 5 , and GxP standards.Collaborate with Quality Assurance, IT, and Regulatory Affairs teams to maintain compliance and support internal and external audits.Develop and maintain validation documentation , including validation plans, specifications, standard operating procedures (SOPs), and risk assessments.Support continuous improvement in validation and documentation processes.Industries & Work EnvironmentsPharmaceutical and medical device manufacturingBiotechnology and life sciences sectorsClinical and laboratory environmentsRequired Skills & QualificationsProven experience in Computer Systems Validation (CSV) within regulated industries.Strong technical writing skills, especially in protocol development and documentation.In-depth understanding of quality assurance , quality control , and software validation.Working knowledge of risk management principles and validation methodologies.Familiarity with automation tools and electronic systems (preferred but not required).Why Join Us100% remote position with flexible scheduling.Opportunity to collaborate with leaders in life sciences and regulatory compliance.Engage in mission-driven validation projects that ensure patient safety and product quality.To Apply :Please submit your resume and a brief summary of your validation and protocol writing experience, including systems or tools you've supported..