Senior CSV Engineer / Senior Validation Engineer

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

Salary: USD80000 - USD115000 per annum

About the Role

A growing life sciences consultancy is seeking a Senior Validation Engineer to join its team of specialists who partner with leading names across the life science industry. The organisation focuses on enabling growth and innovation within the scientific community, helping researchers and companies tackle some of the most pressing challenges in healthcare. Through significant investment in both its people and its capabilities, it delivers solutions and services that support informed, confident decision‑making.

The business grows on the strength of talented professionals who flourish in a collaborative setting and share a common goal: helping life sciences clients improve lives. Every member of the team is committed to making a genuine impact each day.

Culture & Values

• Colleagues are empowered and supported at every level
• Client success is prioritised at every turn
• The team has the courage to always do the right thing
• An inclusive environment is fostered where everyone feels respected, engaged, and challenged
• Continuous learning and skill‑building strengthen the collective expertise of the team

Key Responsibilities

• 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

Requirements

• 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
• 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.