GxP Systems Validation Specialist

EyePoint; Northbridge (MA); On-site; USD 129,000 - 163,000; Full time

Job summary

EyePoint is seeking an IT System and Validation Analyst to ensure CSV compliance for GxP-regulated systems across the enterprise. You will validate, maintain, and retire systems in line with global regulatory requirements while supporting audits and regulatory inspections.

Responsibilities include risk-based validation strategy, lifecycle ownership, and mentoring teammates on regulatory expectations. Collaboration with IT, QC, manufacturing, and quality assurance is essential.

Qualifications

• Experience in Computer System Validation (CSV) within FDA-regulated or GxP environments.
• Knowledge of GAMP 5, 21 CFR Part 11, and EU Annex 11 with risk-based validation approaches.
• Experience validating GxP computerized systems across lab, manufacturing, quality and/or cloud environments.
• Understanding access control, security, audit trails, and data integrity controls in regulated environments.
• Ability to manage GxP system lifecycle activities including change control, deviations, CAPAs, and periodic reviews.

Responsibilities

• Collaborate with GxP system owners to align CSV processes with GAMP 5 and regulatory guidance.
• Provide CSV oversight and lifecycle ownership for new system implementations, upgrades, and decommissioning.
• Author, review, and approve validation deliverables (IQ/OQ/PQ, validation plans, test scripts).
• Categorize and inventory GxP systems to support risk-based validation strategies.
• Ensure validated systems remain in control through change management and periodic reviews.
• Coordinate with vendors for maintenance, upgrades, and supplier assessments to minimize downtime.
• Lead cross-functional teams through validation activities and document rationale.

Skills

CSV experience

GAMP 5

21 CFR Part 11

EU Annex 11

GxP validation

Data integrity

Documentation

Communication

Problem solving

Education

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

Job description

EyePoint is seeking an IT System and Validation Analyst to ensure CSV compliance for GxP-regulated systems across the enterprise. You will validate, maintain, and retire systems in line with global regulatory requirements while supporting audits and regulatory inspections.

Responsibilities include risk-based validation strategy, lifecycle ownership, and mentoring teammates on regulatory expectations. Collaboration with IT, QC, manufacturing, and quality assurance is essential.