6490 - Senior CSV Engineer / Senior Validation Engineer

Senior Validation Engineer Responsibilities:

• Support development of UAT scope, test scenarios, and test scripts based on approved requirements and business processes
• Coordinate and support UAT execution, tester scheduling, evidence collection, defect tracking, retesting, traceability, and closure
• Draft and update SOPs, work instructions, job aids, templates, commissioning documents, and global procedure revisions
• Format documents according to client standards and Good Documentation Practices
• Route documents through the client’s electronic document management system and support review and approval workflows
• Support digitization of document and template libraries, including formatting, metadata, traceability fields, and document tracking
• Develop and format training materials, quick-reference content, and user communications
• Support change-control activities, adoption materials, and implementation action tracking
• Maintain deployment-readiness trackers covering 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
• Assist with translation-package preparation and review coordination for Portuguese, Japanese, and Spanish content
• Coordinate with global C&Q representatives, subject matter experts, Quality, IT, site teams, and external vendors
• Provide clear progress, issue, risk, and action updates

Requirements:

• Bachelors Degree in industry-related discipline
• 5+ years of experience 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
• Experience 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, organization, communication, and stakeholder-coordination skills
• Ability to manage multiple priorities and work independently within a global, cross-functional team
• Experience with digital C&Q, validation, quality, engineering, or manufacturing platforms preferred
• Experience with Kneat or a comparable digital validation solution preferred
• Experience with HP ALM/Quality Center, Jira, or another test-management platform preferred
• Experience with BMSDocs, Documentum, Veeva Vault, or another electronic document management system preferred
• Experience supporting enterprise or multi-site deployments preferred
• Familiarity with change control, training-readiness tracking, go-live, and hypercare preferred
• Experience coordinating translation packages or multilingual document updates. preferred
• This role is remote; limited travel to client site may be requested with advance notice