Computer System Validation (CSV) Engineer Greater Boston - South Shore 3-6 Month Contract (High Potential for Long-term Extension) Compensation: open & flexible No Sponsorship / No Relocation Job Description: We are seeking a Computer System Validation (CSV) Engineer to support our pharmaceutical client's validation initiatives. The ideal candidate will play a critical role in ensuring compliance with industry regulations (FDA, GxP) by validating software systems and processes in a regulated environment. Key Responsibilities: Develop and execute validation protocols (IQ, OQ, PQ) for computerized systems in line with regulatory requirements. Own and drive GMP and Automation projects Ensure compliance with FDA 21 CFR Part 11, GAMP 5, and GxP standards. Collaborate with cross-functional teams, including QA, IT, and system owners, to manage validation activities. Perform risk assessments and document validation deliverables such as Validation Plans, Test Scripts, and Summary Reports. Troubleshoot validation issues and recommend corrective actions. Maintain accurate records and documentation for audits and regulatory inspections. Qualifications: Experience in computer system validation within the pharmaceutical or biotech industry. Strong knowledge of FDA regulations and GxP compliance. Familiarity with validation tools and software systems used in a regulated environment. Preferred: Experience with Lab Systems, ERP systems, LIMS, or other pharmaceutical software. Knowledge of data integrity principles and audit readiness. Please visit our careers page to see more job opportunities. VBB