Senior GxP IT Systems Validation Analyst

Initial Therapeutics, Inc.; Watertown (MA); On-site; USD 129,000 - 163,000; Full time

Job summary

EyePoint is seeking an IT System and Validation Analyst to provide QA oversight of CSV in GxP environments, ensuring systems are validated, compliant, and retired per regulatory guidance. The role partners with GxP owners across IT, QA, Manufacturing and Facilities to drive risk-based validation and data integrity.

This position requires 5-7 years of direct CSV experience, a Bachelor’s degree in engineering or life sciences, and comprehensive knowledge of GAMP 5, 21 CFR Part 11, and EU Annex 11.

Qualifications

• Experience validating GxP computerized systems in FDA-regulated environments.
• Ability to apply risk-based validation per GAMP 5, Part 11, and Annex 11.
• Strong documentation and writing skills for validation deliverables.

Responsibilities

• Provide CSV oversight and lifecycle ownership for new system implementations.
• Author and review validation plans, IQ/OQ/PQ, and validation summary reports.
• Support regulatory inspections and audits with validation documentation.
• Collaborate with IT, QA, and other departments to define validation strategies.
• Maintain system inventories and ensure ongoing data integrity and security.
• Lead cross-functional CSV projects with vendors and MSPs.

Skills

CSV experience

GAMP 5

Part 11

EU Annex 11

Data integrity

Change control

Documentation

Regulatory audits

Cross-functional

Cloud/SaaS

Education

Bachelor's degree in engineering, life sciences, or computer science

Job description

EyePoint is seeking an IT System and Validation Analyst to provide QA oversight of CSV in GxP environments, ensuring systems are validated, compliant, and retired per regulatory guidance. The role partners with GxP owners across IT, QA, Manufacturing and Facilities to drive risk-based validation and data integrity.

This position requires 5-7 years of direct CSV experience, a Bachelor’s degree in engineering or life sciences, and comprehensive knowledge of GAMP 5, 21 CFR Part 11, and EU Annex 11.