IT Systems and Validation Analyst

EyePoint Pharmaceuticals, Inc.•Northbridge, MA

3d•Onsite

About The Position

At EyePoint, leadership trusts our employees to get the job done. The patient-centric and award-winning approach we’re taking in business fuels our: focus on science and innovation, we aim to offer a lifetime of clearer vision commitment to developing and commercializing innovative therapeutics to improve the lives of patients with serious retinal diseases Delivery of innovative therapeutics to protect vision, specializing in sustained-release treatments for serious retinal diseases. We See You. Your wellbeing Your professional worth Your future at EyePoint EyePoint offers robust total rewards in a science-based entrepreneurial culture that empowers curiosity and innovation to help catapult your career. There’s space for every voice and perspective to be heard in our on-site and remote environments where a variety of strengths and diverse backgrounds are connected. This position will report into the Associate Director, IT Systems and Validation. The successful candidate will lead compliance-driven system validations, support IT operations for the site and serve as a strategic liaison between business owners and the broader IT organization. This position plays a key role in ensuring system reliability, regulatory adherence, and seamless integration of technology into manufacturing and laboratory processes.

Requirements

Strong knowledge of GxP regulations, including 21 CFR Part 11, Annex 11, and data integrity principles (ALCOA++).
Experience with computerized system validation (CSV) lifecycle, including requirements development, risk assessment, testing, and documentation.
Proficiency in supporting and troubleshooting Windows-based systems, servers, and enterprise IT infrastructure.
Working knowledge of networking fundamentals, system administration, and cloud platforms (e.g., Azure).
Experience with SQL databases and applications that rely on database backends.
Familiarity with regulated laboratory and/or manufacturing systems
Understanding of access control, security principles, and audit trail requirements in regulated environments.
Ability to manage system lifecycle activities including change control, deviations, CAPAs, and periodic reviews.
Strong documentation skills with experience authoring and maintaining validation and technical support documentation.
Effective communication and collaboration skills, with the ability to interface between technical teams, vendors, and business stakeholders.
Strong analytical and problem-solving skills with the ability to troubleshoot complex system issues in a timely manner.
Bachelor’s degree
Minimum of 4 years’ experience working in Biotech/Pharmaceutical industries, and 4+ years’ experience supporting regulated systems or CSV projects

Responsibilities

Provide support for various regulated systems including laboratory systems, manufacturing equipment, PCs, servers, and associated applications, ensuring optimal functionality and compliance.
Lead or assist in validation efforts for GxP systems, ensuring compliance with regulatory standards and internal quality procedures.
Author and maintain comprehensive validation documentation, including validation plans, user and functional requirements, risk assessments, test scripts, and summary reports.
Lead system assessments (21 CFR Part 11, risk assessments), periodic reviews, and maintain required documentation.
Drive cross-functional system implementations and large-scale validation efforts in collaboration with business partners.
Coordinate with vendors for maintenance, upgrades, and issue resolution to minimize downtime.
Demonstrate proficiency in troubleshooting and supporting Windows operating systems, networks, and cloud platforms such as Azure.
Support SQL databases and provide support for applications and services that rely on these databases.
Provide on-site IT support for the Northbridge facility, including peripherals, laptops, and A/V equipment.
Ensure system reliability and provide proactive maintenance of critical IT infrastructure to support laboratory operations.
Conduct regular system maintenance activities, implement necessary changes, and ensure the overall health and availability of IT systems.
Manage user access controls and permissions to ensure the security and integrity of IT systems and applications.
Respond to technical inquiries and provide solutions in a timely manner to minimize disruptions to laboratory operations.
Coordinate with vendors on application and firmware updates, ensuring that system enhancements are implemented seamlessly.
Notify system owners or business process owners of any planned upgrades, including operating system patches and hot fixes.
Maintain comprehensive documentation of application support and ensure that changes to systems and applications are tracked and updated in accordance with regulatory/internal requirements.