Senior Validation Engineer - Life Sciences (Remote)

Lvi-Associates; Harvard (MA); Hybrid; USD 80,000 - 115,000; Full time

Job summary

Lvi-Associates is seeking a Senior Validation Engineer to join a globally connected team supporting regulated life sciences systems. This remote role focuses on UAT, validation, and controlled documentation, with engagement across QA, IT, and site teams to ensure quality and compliance.

The role emphasizes strong writing and coordination skills, familiarity with GxP practices, and the ability to manage multiple priorities in a global context. Limited client-site travel may be required.

Qualifications

• Bachelor's degree in an industry-related discipline.
• 5+ years supporting regulated life sciences systems, validation, or digital projects.
• Hands-on experience with UAT, test scripts, and regulated documentation.
• Knowledge of GxP, CSV, CSA, validation, or regulated systems.
• Experience authoring or revising SOPs and controlled docs.
• Familiarity with requirements traceability, test evidence, and change control.
• Strong writing, organisation, communication, and stakeholder coordination.
• Ability to work independently in a global cross-functional team.

Responsibilities

• Contribute to UAT scope, test scenarios, and test scripts.
• Coordinate UAT execution, scheduling, evidence collection, defect tracking.
• Author and revise SOPs, work instructions, templates, and documents.
• Format docs to client standards and Good Documentation Practices.
• Route documents through the client’s EDRMS and support review workflows.
• Assist with digitisation of document libraries and templates.
• Produce and format training materials and user communications.
• Support change-control activities, training readiness tracking, and go-live activities.
• Maintain deployment-readiness trackers for access, training, and readiness.
• Support go-live and hypercare activities, including issue logging and resolution tracking.
• Help prepare translation packages and coordinate reviews for multilingual content.
• Liaise with global C&Q, QA, IT, site teams, and vendors.
• Deliver updates on progress, issues, risks, and actions.

Skills

Stakeholder coordination

Writing & communication

Independent working

Education

Bachelor's degree in an industry-related discipline

Tools

Kneat

HP ALM/Quality Center

Veeva Vault

Documentum

Jira

Job description

Lvi-Associates is seeking a Senior Validation Engineer to join a globally connected team supporting regulated life sciences systems. This remote role focuses on UAT, validation, and controlled documentation, with engagement across QA, IT, and site teams to ensure quality and compliance.

The role emphasizes strong writing and coordination skills, familiarity with GxP practices, and the ability to manage multiple priorities in a global context. Limited client-site travel may be required.