> Markdown version of [/jobs/ext/209867-csv-specialist](https://www.wearedevelopers.com/jobs/ext/209867-csv-specialist). Every page supports `.md` or `Accept: text/markdown`. Links point to the HTML versions so they work for humans too. Agent guide: [/agents.md](https://www.wearedevelopers.com/agents.md). --- # CSV Specialist - **Company:** Insight Global - **Location:** Merion Station, PA, United States - **Experience:** Experienced - **Contract:** Permanent contract - **Skills:** Microsoft Windows, Data Integrity, Regression Testing, System Testing, Iq/oq/pq, Information Technology, GXP - **Published:** May 15, 2026 - **Apply:** https://dejobs.org/x/x/D62CBC9785264AD5967F60D312BAA89C/job/ ## About the Role Bachelor's degree in Engineering, Computer Science, Life Sciences, or related field. 3-7+ years of experience in a GMP biopharmaceutical, biotech, or pharmaceutical environment. Kneat experience Experience with CSV or Validation ## Description One of our large biopharmaceutical clients is seeking a CSV specialist to join their team for a Windows 11 upgrade. This role focuses on assessing system impact, executing validation deliverables, coordinating with IT and Quality, and ensuring that all upgraded platforms meet regulatory, data integrity, and business continuity requirements. The ideal candidate brings deep experience in Computer System Validation (CSV) within a regulated biopharmaceutical environment and is comfortable working at the intersection of IT infrastructure and GMP operations., Work on CSV activities related to the Windows 11 operating system upgrade across GxP-impacted systems and applications. Perform system impact assessments, risk evaluations, and gap analyses to determine validation scope. Develop and execute validation documentation, including URS, FRS, RTM, IQ/OQ/PQ, and validation summary reports. Partner with IT, Quality Assurance, and system owners to ensure compliant implementation and smooth transition of validated systems. Review vendor documentation and assess suitability for GMP use. Ensure all changes follow change control, deviation management, and data integrity requirements. Support testing activities, including regression testing, functional verification, and system compatibility checks. Maintain clear documentation and traceability throughout the validation lifecycle. Provide guidance on regulatory expectations related to OS upgrades, cybersecurity, and system lifecycle management. Support audits and inspections by providing validation evidence and subject-matter expertise. We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/. ## Related Videos - [Replacing Excel with SAP APIs & Python validation](https://www.wearedevelopers.com/videos/1944-replacing-excel-with-sap-apis-python-validation) - [Blueprints for Success: Steering a Global Data & AI Architecture](https://www.wearedevelopers.com/videos/1577-blueprints-for-success-steering-a-global-data-ai-architecture) - [Exploring 5 Key Applications of AI Abundance with Blockchain Assurance](https://www.wearedevelopers.com/videos/971-exploring-5-key-applications-of-ai-abundance-with-blockchain-assurance) - [Database Magic behind 40 Million operations/s](https://www.wearedevelopers.com/videos/748-database-magic-behind-40-million-operations-s) - [Startup Presentation: StorX - Future of Cloud Storage](https://www.wearedevelopers.com/videos/1176-startup-presentation-storx-future-of-cloud-storage) - [Database DevOps with Containers](https://www.wearedevelopers.com/videos/145-database-devops-with-containers) ## Related Articles - [The 8 Best Code Testing Tools](https://www.wearedevelopers.com/magazine/402-the-8-best-code-testing-tools) - [The Most Popular IT Jobs on the Market](https://www.wearedevelopers.com/magazine/376-the-most-popular-it-jobs-on-the-market) - [Where to Find Entry-Level Software Engineering Jobs](https://www.wearedevelopers.com/magazine/397-where-to-find-entry-level-software-engineering-jobs) - [System change: restart as developer?](https://www.wearedevelopers.com/magazine/39-system-change-restart-as-developer) - [Data Engineer Salary UK](https://www.wearedevelopers.com/magazine/253-data-engineer-salary-uk) - [Where To Find Software Engineering Jobs](https://www.wearedevelopers.com/magazine/396-where-to-find-software-engineering-jobs)