Hiring: IT System and Validation Analyst Company: EyePoint Location: Northbridge, MA Job Posted Time: 2026-09-03 11:22:51 Target Skills & Keywords : Change Management, Quality Assurance, Regulatory Compliance, SaaS About the job Experience: •5-7 years of direct CSV experience within an FDA-regulated or GxP environment (pharmaceutical, biotechnology, medical device, or similar). •7 years of direct CSV experience within an FDA-regulated or GxP environment (pharmaceutical, biotechnology, medical device, or similar). Required Skills: •Partner cross-functionally 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. •User Requirements Specifications (URS) and Functional Specifications (FS) •IQ/OQ/PQ Protocols and Test Scripts •Data Integrity, System Impact and Part 11 Assessments •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. Qualifications: •With the exciting energy of a winning culture and an exhilarating pace, we are an ophthalmology company committed to preventing blindness by developing and commercializing innovative therapeutics. •The collective power of our values influences everything we do, and everything we do for you. •We exist to change our patients’ lives through the power of sight. We are forward looking, embrace challenges with curiosity, and continuously seek to improve our products and ourselves by learning, problem-solving and pushing the limits of science and technology. •We recognize our responsibility to our patients, employees, and our community, and value the trust they put in us. We set a high ethical bar and expect responsible leadership at every level to ensure we serve those who matter most to us. •We believe that fun and excellence can coexist. We foster a culture where enjoying the work we do and caring for each other are as important as delivering exceptional outcomes. •We strive to see through the eyes of others and work as one team. We appreciate one another’s differences and perspectives, and ensure everyone feels valued, respected and encouraged to bring their ideas forward. Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!