Senior Validation Engineer - CSV for Life Sciences (Remote)

LVI Associates; Harvard (MA); On-site; USD 90,000 - 135,000; Full time

Job summary

LVI Associates is seeking a Senior Validation Engineer to join a team delivering lifes science validation projects for leading clients. You will contribute to UAT scope, author SOPs, and ensure documentation aligns with client standards and regulatory expectations.

You will coordinate UAT, manage traceability, and support go-live activities while liaising with global Q&C and IT teams. Remote work with periodic client-site travel is possible.

Qualifications

• 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.
• Track record of authoring or revising SOPs, work instructions, test scripts, 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.

Responsibilities

• Contribute to UAT scope, test scenarios, and test scripts from approved requirements.
• Coordinate and support UAT execution, scheduling, evidence collection, defect tracking, retesting, and closure.
• Author and revise SOPs, work instructions, templates, and commissioning documents.
• Format documentation per client standards and Good Documentation Practices.
• Route documents through the client's EDRMS and support review workflows.
• Digitise document and template libraries, including metadata and traceability fields.
• Produce training materials, quick-reference guides, and user communications.
• Support change-control activities, readiness tracking, and go-live documentation.
• Assist with translation packages for Portuguese, Japanese, and Spanish content.
• Liaise with global Q&C representatives, SMEs, IT, site teams, and external vendors.
• Deliver updates on progress, issues, risks, and actions.

Skills

UAT

Test Script Development

Documentation

Regulated Environments

Stakeholder Coordination

Education

Bachelor's degree in an industry-related discipline

Tools

HP ALM/Quality Center

Jira

Kneat

Veeva Vault

Documentum

Job description

LVI Associates is seeking a Senior Validation Engineer to join a team delivering lifes science validation projects for leading clients. You will contribute to UAT scope, author SOPs, and ensure documentation aligns with client standards and regulatory expectations.

You will coordinate UAT, manage traceability, and support go-live activities while liaising with global Q&C and IT teams. Remote work with periodic client-site travel is possible.