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Agent guide: [/agents.md](https://www.wearedevelopers.com/agents.md). --- # CSV - Quality Systems Specialist - **Company:** Reckitt Benckiser Group PLC. - **Location:** Wilson, NC, United States - **Experience:** Experienced - **Salary:** $85,000.0 - $127,000.0 - **Contract:** Permanent contract - **Skills:** Software Applications, Data Integrity, Laboratory Information Management Systems, Systems Development Life Cycle, SAP (Applications), Software Engineering, System Testing, Web Platforms, Iq/oq/pq, Computerised Systems, Information Technology, Intercompany Hub, GXP - **Published:** July 24, 2026 - **Apply:** https://careers.reckitt.com/talentcommunity/apply/1415903833/?locale=en_GB ## About the Role * Bachelor's degree in Computer Science, Engineering, Life Sciences, or a related field with 3-5 years of Computer System Validation (CSV) experience in pharmaceutical or other highly regulated industries. * Hands-on experience executing the full validation lifecycle, including system validation, Computer Software Assurance (CSA), data integrity initiatives, and software development lifecycle (SDLC) activities. * Experience applying FDA regulations, GAMP 5, ICH Q7-Q10, 21 CFR Part 11, and other regulatory requirements to validated systems and compliance programs. * Proven experience supporting regulatory audits, inspections, and validation activities while maintaining compliant documentation in accordance with quality and regulatory standards. * Demonstrated success managing multiple validation projects, partnering with cross-functional teams, and driving compliance and continuous improvement initiatives in fast-paced environments. The skills for success Commercial Awareness, Business Partnership, Collaboration, Partnership building, Ability to challenge the status quo, Propose improvement, Accountability, Adaptability, Collaborator, R&D, Product Lifecycle Management. ## Description The CSV Specialist is responsible for supporting the validation lifecycle of GxP-regulated computerized systems. This role ensures that enterprise systems such as LIMS, PAS-X, SAP and site digital platforms meet regulatory requirements and internal standards for data integrity, compliance, and operational effectiveness., * Develop and execute Computer System Validation (CSV) deliverables, including URS, FRS, IQ/OQ/PQ protocols, validation reports, periodic reviews, and revalidation activities. * Ensure compliance with regulatory requirements and industry standards, including 21 CFR Part 11, Annex 11, GAMP 5, data integrity, SOPs, and CSA methodologies where applicable. * Support change controls, investigations, CAPAs, risk assessments, and audit/inspection activities while maintaining accurate, complete, and audit-ready validation documentation. * Partner with IT, Quality, and technical teams to implement, validate, and sustain compliant computerized systems and documentation processes. * Train end users on validated systems and CSV procedures, maintain SOPs and templates, and drive continuous improvement initiatives to enhance compliance, efficiency, and performance. 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