IT System and Validation Analyst

The General & Administrative (G&A) functional teams at EyePoint include Finance and Accounting, Human Resources, Information Technology, Legal, and Compliance. This team ensures the company operates efficiently and effectively while maintaining high standards in the regulated environment (FDA, SEC, etc.) where we operate. In parallel, the G&A organization is an important partner as EyePoint advances therapeutics to improve the lives of patients with serious retinal diseases.

The IT System and Validation Analyst is responsible for QA oversight of the validation and compliance of GxP-regulated computerized systems ensuring they are implemented, maintained, and retired in accordance with global regulatory requirements, industry standards, and internal procedures.

This is a hybrid opportunity with 4 days onsite with travel between our Watertown & Northbridge locations.

Primary responsibilities include, but are not limited to, the following:

Individual Responsibilities

GxP Systems & Applications

• Collaborate with GxP system business owners to ensure internal CSV processes and procedures are aligned to GAMP 5, 21 CFR Part 11, EU Annex 11, and FDA's Computer Software Assurance (CSA) guidance.
• Serve as a subject matter expert (SME) providing qualification and validation expertise to CMC, Manufacturing Operations, Facilities, Quality Control, Quality Assurance, and Engineering departments.
• Provide CSV oversight and lifecycle ownership for new computerized system implementations, upgrades, integrations, cloud/SaaS solutions, migrations, and decommissioning activities.
• Author, review, and/or approve validation deliverables across the full CSV lifecycle, including but not limited to:
• Validation Plans
• User Requirements Specifications (URS) and Functional Specifications (FS)
• Risk Assessments
• Traceability Matrices
• IQ/OQ/PQ Protocols and Test Scripts
• Validation Summary Reports
• Data Integrity, System Impact and Part 11 Assessments
• Operating and Administrative Procedures
• Periodic Review and System Retirement/Archival Plans
• Categorize and maintain an inventory of GxP computerized systems using GAMP 5 system categories to support risk-based validation strategies.
• Ensure validated systems remain in a state of control through change management, periodic review, requalification, deviation management, CAPA, etc.
• Collaborate with internal stakeholders and business process owners to define validation strategies, risk-based approaches, and compliant delivery models aligned with GxP expectations.
• Coordinate with vendors and managed service providers for maintenance, upgrades, supplier assessments, and issue resolution to minimize system downtime and ensure continued compliance.
• Author, review, and maintain SOPs, work instructions, and templates related to computer system validation and data integrity.
• Support regulatory inspections, internal audits, and external audits by providing validation documentation, system rationale, and SME responses as needed.
• Identify and escalate data integrity risks and compliance gaps, recommending remediation strategies consistent with applicable regulatory guidance.
• Provide expertise and mentoring to cross-functional team members on CSV concepts, regulatory expectations, and documentation standards.
• Provide administrative ownership of released systems for activities such as creating users, supplier change notifications, basic issue resolution, etc
• Ability to lead and coordinate cross-functional project teams — including IT, Quality, business process owners, and vendors - through validation activities, ensuring alignment on scope, timelines, and deliverables.

Primary skills and knowledge required include, but are not limited to the following:

• Previous experience in Computer System Validation (CSV) within an FDA-regulated or GxP environment.
• Strong working knowledge of GAMP 5, 21 CFR Part 11, and EU Annex 11 with the ability to apply risk-based validation strategies.
• Experience validating GxP computerized systems across laboratory, manufacturing, quality and/or cloud-based environments.
• Understanding of access control, security principles, audit trail requirements, and data integrity controls in regulated environments.
• Ability to manage GxP system lifecycle activities including change control, deviations, CAPAs, periodic reviews, etc.
• Strong documentation and technical writing skills with experience authoring validation plans, requirements, risk assessments, test protocols, summary reports, etc.
• Effective communication and collaboration skills, with proven ability to interface between technical teams, vendors, and business stakeholders.
• Strong analytical and problem-solving skills with the ability to troubleshoot complex system and compliance issues in a timely manner.
• High attention to detail and commitment to data integrity and regulatory compliance.
• Experience supporting audits, inspections, supplier assessments, or compliance remediation programs.

Level of Education Required:

Bachelor's degree in Engineering, Life Sciences, Computer Science, or a related technical discipline; master's degree a plus.

Number of Years of Experience in the Function and in the Industry:

Minimum 5-7 years of direct CSV experience within an FDA-regulated or GxP environment (pharmaceutical, biotechnology, medical device, or similar).