CSV Validation Lead – GxP IT Systems

BioSpace; Watertown (MA); On-site; USD 129,000 - 163,000; Full time

Job summary

EyePoint Pharmaceuticals seeks an IT System and Validation Analyst to lead QA oversight of CSV for GxP-regulated computerized systems. You will ensure implementation, maintenance, and retirement align with global regulatory requirements and internal procedures, collaborating with CMC, Manufacturing,Facilities, QA, and Engineering.

Ideal candidates hold a Bachelor’s in a technical field with 5-7 years of CSV experience and strong documentation skills.

Qualifications

• Experience in Computer System Validation (CSV) in FDA-regulated or GxP environments.
• Bachelor level education in a technical discipline is required.
• Strong documentation and writing skills for validation deliverables such as IQ/OQ/PQ, validation plans and test scripts.
• Experience partnering with multiple departments (CMC, Manufacturing, Facilities, QA, Engineering).
• Ability to lead cross-functional project teams through validation activities.

Responsibilities

• Provide QA oversight of validation and compliance for GxP-regulated systems.
• Author, review, and approve validation deliverables across CSV lifecycle.
• Coordinate with vendors and service providers to minimize system downtime.
• Support regulatory inspections and internal/external audits with validation documentation.
• Mentor cross-functional teams on CSV concepts and regulatory expectations.

Skills

GxP validation

Regulatory compliance

Documentation

Cross-functional collaboration

Project leadership

Quality systems

Quality audits

Education

Bachelor's degree in Engineering, Life Sciences, Computer Science, or related

Tools

GAMP 5

21 CFR Part 11

EU Annex 11

Job description

EyePoint Pharmaceuticals seeks an IT System and Validation Analyst to lead QA oversight of CSV for GxP-regulated computerized systems. You will ensure implementation, maintenance, and retirement align with global regulatory requirements and internal procedures, collaborating with CMC, Manufacturing,Facilities, QA, and Engineering.

Ideal candidates hold a Bachelor’s in a technical field with 5-7 years of CSV experience and strong documentation skills.