IT Systems and Validation Analyst

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 contributi…

Eyepoint Pharmaceuticals is hiring a Senior Validation Engineer to lead compliance and quality assurance efforts at its Northbridge, MA site. This position plays a central role in supporting validation activities tied to regulatory compliance, NDA submissions, and preparation for commercial launches. The Senior Validation Engineer provides broad oversight of validation projects to ensure all work aligns with regulatory requirements and internal quality standards. What you will do Guide and coordinate validation activities across process validation (PV), Process Performance Qualification (PPQ), facility and utility qualification, equipment qualification, computer system validation (CSV), and automation or controls validation. Oversee the entire validation lifecycle, including planning, execution, and documentation. Confirm that validation deliverables meet both regulatory expectations and internal quality protocols. Prepare and maintain validation documentation for inspections and regulatory reviews. Work location and schedule This position is based at the Northbridge, MA facility. Eyepoint Pharmaceuticals offers a hybrid work schedule.

As a Senior Quality Validation Engineer at EyePoint Pharmaceuticals, you will play a pivotal role in ensuring the quality and compliance of our drug development processes. Reporting directly to the Director of Quality Engineering, you will contribute to both the development and validation of drug substances and drug products.This position offers a hybrid work schedule, promoting a balance between in-office collaboration and remote work flexibility.Key Responsibilities:Oversee quality validation and qualification processes related to drug substance and product development, including the creation and refinement of test methods and specifications.Ensure quality oversight for packaging processes as we prepare for commercialization.Lead cross-functional teams in maintaining validation documentation throughout its lifecycle, including Process Risk Assessments and Change Controls.Additionally, you will:Collaborate with internal stakeholders to review and approve validation and qualification documentation related to drug products.Ensure our facility remains compliant with regulatory requirements and is always inspection-ready, adhering to EyePoint's procedures and policies.Primary Responsibilities:Provide quality engineering expertise to the Research and Development, Manufacturing, Facilities, and Engineering teams.Establish and maintain quality and compliance systems that align with industry and regulatory standards.Work closely with Development and Engineering teams to ensure effective implementation of drug process development requirements.Engage with external partners on process validation initiatives.Utilize systematic problem-solving methodologies to identify and resolve quality issues.Lead the development and modification of validation packages, including risk assessments and validation protocols.Review processes and test methods to ensure robust quality control analysis.Participate in risk analysis related to Quality events such as CAPA and deviations.Contribute to continuous improvement initiatives.