EyePoint Pharmaceuticals logoEyePoint Pharmaceuticals logo

IT Systems and Validation Analyst

Hybrid Full-time $128.8K/yr - $163.1K/yr

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Experience Level

Experience

Qualifications

Qualifications:Strong understanding of GxP regulations and compliance standards. Experience with IT systems validation and documentation practices. Excellent communication and interpersonal skills. Ability to work collaboratively in a team-oriented environment.

About the job

EyePoint Pharmaceuticals is seeking an IT Systems and Validation Analyst who will report directly to the Associate Director of IT Systems & Validation. In this pivotal role, you will oversee compliance-driven system validations, support IT operations on-site, and act as a vital link between business stakeholders and the wider IT organization. Your contribution will be crucial in maintaining system reliability, ensuring adherence to regulatory standards, and facilitating the seamless integration of technology within our manufacturing and laboratory processes.

This position is based in Northbridge, MA, and offers a hybrid work schedule.

Key Responsibilities:

  • Provide support for a range of validated systems, including laboratory systems, manufacturing equipment, PCs, servers, and associated applications, to ensure optimal performance and compliance.
  • Lead or assist in validation initiatives for GxP systems, ensuring compliance with both regulatory standards and internal quality guidelines.
  • Create and manage comprehensive validation documentation, which includes validation plans, user specifications, functional requirements, risk assessments, test scripts, and summary reports.
  • Conduct system assessments (21 CFR Part 11, risk assessments), execute periodic reviews, and maintain necessary documentation.
  • Drive cross-functional system implementations and extensive validation projects in collaboration with business partners.

About EyePoint Pharmaceuticals

At EyePoint Pharmaceuticals, we are dedicated to transforming the treatment of eye diseases through innovative drug delivery systems. We are at the forefront of ophthalmology, providing patients with solutions that improve their quality of life. Join us in our mission to redefine eye care.

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