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# Senior CSV Engineer / Senior Validation Engineer

- **Company:** LVI Associates
- **Location:** Harvard, MA, United States (Remote available)
- **Experience:** Expert
- **Contract:** Permanent contract
- **Skills:** JIRA, Software Bug Management, Document Management Systems, Documentum, HP Quality Centers, Regression Testing, Requirements Traceability, Data Logging, Test Scripts, Hp Alm, VeevaVault, GXP
- **Published:** August 30, 2026
- **Apply:** https://www.disabledperson.com/jobs/74649653-senior-csv-engineer-senior-validation-engineer

## About the Role

* Bachelor's degree in an industry-related discipline
 * 5+ years supporting regulated life sciences systems, validation, quality, engineering, or digital transformation projects
 * Hands-on experience with UAT, test-script development, regulated documentation, or system deployment activities
 * Working knowledge of GxP, CSV, CSA, validation, or regulated system implementation practices
 * A track record of authoring or revising SOPs, work instructions, test scripts, job aids, templates, or other controlled documentation
 * Familiarity with requirements traceability, test evidence, defect management, document workflows, or deployment-readiness tracking
 * Strong writing, organisation, communication, and stakeholder-coordination skills
 * Comfortable managing competing priorities and working independently within a global, cross-functional team

Preferred:

 * Experience with digital C&Q, validation, quality, engineering, or manufacturing platforms
 * Experience with Kneat or a comparable digital validation solution
 * Experience with HP ALM/Quality Center, Jira, or another test-management platform
 * Experience with BMSDocs, Documentum, Veeva Vault, or another electronic document management system
 * Experience supporting enterprise or multi-site deployments
 * Familiarity with change control, training-readiness tracking, go-live, and hypercare
 * Experience coordinating translation packages or multilingual document updates

This role is remote; limited travel to the client site may be requested with advance notice.

## Description

* Contribute to the development of UAT scope, test scenarios, and test scripts drawn from approved requirements and business processes
 * Coordinate and support UAT execution, including tester scheduling, evidence collection, defect tracking, retesting, traceability, and closure
 * Author and revise SOPs, work instructions, job aids, templates, commissioning documents, and global procedure updates
 * Format documentation in line with client standards and Good Documentation Practices
 * Route documents through the client's electronic document management system and support review and approval workflows
 * Assist with the digitisation of document and template libraries, covering formatting, metadata, traceability fields, and document tracking
 * Produce and format training materials, quick-reference guides, and user communications
 * Support change-control activities, adoption materials, and implementation action tracking
 * Maintain deployment-readiness trackers spanning user access, training completion, readiness checklists, cutover inputs, and open actions
 * Support go-live and hypercare activities, including issue logging, routing, follow-up, and resolution tracking
 * Help prepare translation packages and coordinate reviews for Portuguese, Japanese, and Spanish content
 * Liaise with global C&Q representatives, subject matter experts, Quality, IT, site teams, and external vendors
 * Deliver clear updates on progress, issues, risks, and actions


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