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Agent guide: [/agents.md](https://www.wearedevelopers.com/agents.md). --- # Senior CSV Validation Engineer in Lexington - **Company:** Energy Jobline - **Location:** Lexington, KY, United States - **Experience:** Expert - **Salary:** $115,000.0 - $140,000.0 - **Contract:** Permanent contract - **Skills:** Microsoft Word, Microsoft Excel, Adobe Acrobat, Data Analysis, Software Applications, Audit Trail, Data Integrity, Data Retention, Electronic Signatures, Microsoft Office, Microsoft Visio, Verification and Validation (Software), Data Streaming, System Testing, Iq/oq/pq, Computerised Systems, Information Technology, GXP - **Published:** September 11, 2026 - **Apply:** https://www.energyjobline.com/job/senior-csv-validation-engineer-lexington-31617735 ## About the Role * A minimum of a bachelor's degree in Engineering, Computer Science or related discipline, * 7+ years of Computer System Validation experience * Strong understanding of GxP computerized systems and validation principles with experience leading validation projects for Enterprise, Laboratory, Manufacturing, and Quality Systems. * Demonstrated experience developing and executing risk-based CSV strategies * Experience with computerized system periodic reviews * Experience with audit trail and data integrity assessments SKILLS / ABILITIES * The ability to communicate effectively with employees of all experience levels from Genezen and other contract firms * The ability to report on project activity in a clear and concise manner * The ability to communicate and work effectively with fellow project team members * Ability to work well with diverse groups in a matrix-style, growing, safety focused organization * Understanding of cGMP regulations * Strong technical writing skills * Strong working knowledge in Microsoft Office (Word, Excel, Visio, etc.) and Adobe Acrobat * Strong project management skills with the ability to manage multiple activities with challenging timelines * Strong working knowledge of 21 CFR Part 11, EU GMP Annex 11, ICH guidelines, GAMP 5 and data integrity guidelines, We are committed to scientific excellence, staying current with industry developments, making data-driven decisions, and pursuing innovation to advance healthcare. Urgency in action for the patients We operate with urgency and a commitment to delivering timely treatments to patients by accelerating our partners' programs. Resilience & Grit in operations We are committed to overcoming challenges, learning from failures, and persistently striving for success. Execute with Excellence & Integrity We are dedicated to delivering quality results and upholding ethical principals. Solutions driven for our partners We are committed to being a proactive, collaborative, creative and open-minded partner. ## Description The incumbent is responsible for leading computerized systems validation projects and supporting the data integrity program. This includes qualification of GxP computerized systems for both laboratory and manufacturing based equipment as well as GxP software applications. Key deliverables are preparation of relevant documentation (Validation Plans, User Requirements Specifications (URS), Risk Assessments, IQ/OQ/PQ protocols and Traceability Matrices) to meet regulatory requirements for new and existing products. Collaborates with cross functional teams, ensuring compliance with regulatory requirements, and drives best-in-class validation practices that support our Quality Management System and operational excellence., * Lead risk-based validation strategies for GxP computerized systems throughout the system lifecycle including protocol , oversee execution, data analysis, report and approval of qualification activities for GxP software applications * Review and approve qualification documentation on behalf of the validation function * Evaluate, audit, and guide software validation activities to ensure compliance with FDA, EU, ISO, Data Integrity guidances, and internal procedures and standards * Assess the impact of system-related events on the system's validated state and data reliability. * Lead validation execution and ensure testing is appropriately documented * Support quality events involving CSV in protocol nonconformances, deviations, investigations, CAPAs, and change controls. Serve as initiator and owner of validation related change controls and corrective and preventative actions * Develop, author and improve CSV procedures, templates, standards, and guidance. Monitor industry and regulatory trends and recommend improvements to company practices * Support the execution and of formal risk assessments * Support and conduct periodic reviews * Support the evaluation of data lifecycles and data flow from creation through processing, review, approval, reporting, retention, and archival * Support risk-based Data Integrity Assessments and the audit trail review process * Identify data integrity risks and partner with system owners to implement remediation plans * Provide CSV and Data Integrity expertise during vendor selection and qualification. Define expectations for vendor testing, validation documentation, audit trails, electronic signatures, and data retention. * Provide guidance to project teams, system owners, IT, and vendors regarding GxP validation requirements * Promote a strong data integrity culture across GxP functions * Support audits and regulatory inspections in representing CSV, as needed, * Adaptability required as work schedule may change based on business needs * Criminal background check required * Other duties as assigned ## 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) - [Resilient by Design: Building Robust Architectures in High-Stakes Financial Systems](https://www.wearedevelopers.com/videos/2106-resilient-by-design-building-robust-architectures-in-high-stakes-financial-systems) - [Great DevEx and Regulatory Compliance - Possible?](https://www.wearedevelopers.com/videos/1426-great-devex-and-regulatory-compliance-possible) - [No Keys for the Robot: GitOps as the Control Plane for Autonomous Agents](https://www.wearedevelopers.com/videos/100095-no-keys-for-the-robot-gitops-as-the-control-plane-for-autonomous-agents) - [One Pipeline, Three Regulator - SBOM Compliance for the Developer](https://www.wearedevelopers.com/videos/100169-one-pipeline-three-regulator-sbom-compliance-for-the-developer) - [How One Developer Built the Back Office for 10 Million Companies](https://www.wearedevelopers.com/videos/100082-how-one-developer-built-the-back-office-for-10-million-companies) ## Related Articles - [How We Built a Worry-Free System That Runs for 10+ Years – And What We’d Do Again](https://www.wearedevelopers.com/magazine/751-how-we-built-a-worry-free-system-that-runs-for-10-years-and-what-we-d-do-again) - [Fully Remote Software Engineer Jobs](https://www.wearedevelopers.com/magazine/447-fully-remote-software-engineer-jobs) - [A Guide to Green Tech and Green IT Careers](https://www.wearedevelopers.com/magazine/374-a-guide-to-green-tech-and-green-it-careers) - [Where to Find Entry-Level Software Engineering Jobs](https://www.wearedevelopers.com/magazine/397-where-to-find-entry-level-software-engineering-jobs) - [Where To Find Software Engineering Jobs](https://www.wearedevelopers.com/magazine/396-where-to-find-software-engineering-jobs) - [Data Engineer Salary UK](https://www.wearedevelopers.com/magazine/253-data-engineer-salary-uk)