Jobs → Engineering → Lead Computer System Validation Engineer

About the Role We are looking for an experienced Lead CSV Engineer to lead computer system validation activities and ensure compliance across GxP-regulated pharmaceutical and biotechnology environments. Key Responsibilities • Lead CSV and CSA activities for computerized systems across laboratory, manufacturing, quality, and IT environments. • Develop, review, and approve validation documents, including URS, risk assessments, RTMs, IQ/OQ/PQ protocols, test scripts, and validation summary reports. • Ensure compliance with GAMP 5, FDA 21 CFR Part 11, EU GMP Annex 11, and ALCOA+ data integrity principles. • Oversee system implementation, integration testing, upgrades, and lifecycle management. • Manage deviations, CAPAs, change controls, remediation activities, and periodic system reviews. • Validate and support GxP applications such as TrackWise, Empower CDS, SAP, LIMS, and MES. • Coordinate with IT, QA, Engineering, R&D, business stakeholders, and external vendors. • Support audits, regulatory inspections, and computerized system compliance activities. • Provide technical leadership and guidance to CSV engineers and cross-functional teams. Requirements • Bachelor's degree in Engineering, Computer Science, IT, Life Sciences, or a related field. • Minimum 8+ years of experience in CSV, CSA, or computerized system compliance within pharmaceutical or biotechnology industries. • Strong knowledge of GAMP 5, 21 CFR Part 11, EU GMP Annex 11, and data integrity requirements. • Experience with risk-based validation, SDLC, system integration testing, and validation documentation review. • Hands-on experience managing deviations, CAPAs, change controls, and system lifecycle activities. • Strong technical writing, leadership, communication, and stakeholder management skills. Mandatory Requirement • Candidates must provide 2 Manager-level professional references along with their resume for consideration. • U.S.-based candidates only. W2 Contract engagement only.