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Agent guide: [/agents.md](https://www.wearedevelopers.com/agents.md). --- # CSV Engineer - **Company:** Katalyst Talent Agency - **Location:** New Wilmington, PA, United States - **Contract:** Permanent contract - **Skills:** Artificial Intelligence, Software Applications, Audit Trail, Data Validation, Data Visualization, Laboratory Information Management Systems, SAP (Applications), System Testing, Iq/oq/pq, Enterprise Software Applications, Computerised Systems, Information Technology, VeevaVault, GXP - **Published:** May 14, 2026 - **Apply:** https://www.indeed.com/viewjob?jk=fa5629af6088a73b ## About the Role Do you have experience in SOX?, * Bachelor's or Master's degree in Computer Science, Life Sciences, Engineering, Pharmacy, or related field. * Experience in Computer System Validation (CSV) within pharmaceutical or life sciences regulated environments. * Strong knowledge of GxP regulations, 21 CFR Part 11, GAMP 5, EU Annex 11, ISO 9001, and SOX compliance requirements. * Experience with validation of enterprise systems such as Veeva Vault, SAP GxP modules, LIMS, and electronic quality systems. * Familiarity with risk-based validation approaches and CSA (Computer Software Assurance) methodologies. * Exposure to validation documentation lifecycle including URS, FRS, IQ/OQ/PQ, RTM, and validation reports. * Understanding of audit processes, CAPA management, deviation handling, and change control systems. * Knowledge of pharmaceutical domains such as Clinical, Pharmacovigilance, Regulatory Affairs, Manufacturing, and Medical Affairs is preferred. * Experience with tools like Veeva Vault, Labware LIMS, SAP, and electronic lab notebooks is an advantage. ## Description The CSV Engineer / Validation Engineer will be responsible for ensuring computerized systems in a regulated pharmaceutical environment comply with GxP, 21 CFR Part 11, GAMP 5, EU Annex 11, ISO 9001, and SOX requirements. The role involves supporting validation activities using a risk-based approach aligned with CSA principles, ensuring systems are audit-ready, and maintaining compliance throughout the system lifecycle. The position also requires hands-on involvement in documentation, validation execution, and quality governance for enterprise systems such as Veeva Vault, SAP GxP modules, and LIMS platforms., * Ensure compliance of computerized systems with regulatory standards including 21 CFR Part 11, GxP, GAMP 5, EU Annex 11, ISO 9001, SOX, and ITIL frameworks. * Perform audit readiness activities including periodic system reviews, access control evaluations, and audit trail reviews. * Manage and execute validation lifecycle documentation including URS, FRS, Validation Plans, Protocols (IQ/OQ/PQ), RTM, and Validation Summary Reports. * Support deviation management, CAPA execution, and change control processes in alignment with SOP and quality policies. * Apply risk-based validation strategies aligned with CSA (Computer Software Assurance) principles. * Provide validation support for enterprise systems such as Veeva Vault suite, SAP GxP modules, Labware LIMS, Biovia ELN, and other regulated platforms. * Collaborate with cross-functional teams in Clinical, Pharmacovigilance, Regulatory Affairs, Medical Affairs, Discovery, and Manufacturing domains. * Support implementation and validation of RPA GxP bots and AI/ML-based regulatory and manufacturing systems. * Ensure quality system compliance through documentation review, SOP adherence, and governance activities. * Contribute to validation of data visualization tools and analytics platforms used in regulated environments. ## Related Videos - [Blueprints for Success: Steering a Global Data & AI Architecture](https://www.wearedevelopers.com/videos/1577-blueprints-for-success-steering-a-global-data-ai-architecture) - [Navigating the Corporate Jungle: Life as a Developer in a large Company](https://www.wearedevelopers.com/videos/621-navigating-the-corporate-jungle-life-as-a-developer-in-a-large-company) - [Valven Atlas: Engineering Intelligence That Delivers](https://www.wearedevelopers.com/videos/1660-valven-atlas-engineering-intelligence-that-delivers) - [One Pipeline, Three Regulator - SBOM Compliance for the Developer](https://www.wearedevelopers.com/videos/100169-one-pipeline-three-regulator-sbom-compliance-for-the-developer) ## Related Articles - [Highest Paying Tech Companies for Developers](https://www.wearedevelopers.com/magazine/220-highest-paying-tech-companies-for-developers) - [Where To Find Software Engineering Jobs](https://www.wearedevelopers.com/magazine/396-where-to-find-software-engineering-jobs) - [The 8 Best Code Testing Tools](https://www.wearedevelopers.com/magazine/402-the-8-best-code-testing-tools) - [Where to Find Entry-Level Software Engineering Jobs](https://www.wearedevelopers.com/magazine/397-where-to-find-entry-level-software-engineering-jobs) - [The Most Popular IT Jobs on the Market](https://www.wearedevelopers.com/magazine/376-the-most-popular-it-jobs-on-the-market) - [Fully Remote Software Engineer Jobs](https://www.wearedevelopers.com/magazine/447-fully-remote-software-engineer-jobs)