Senior Quality Validation Engineer - Drug Development

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.

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.

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.

Role overview The Director of Quality Operations oversees global GMP quality at Eyepoint Pharmaceuticals, supporting both internal and external manufacturing. This position plays a key role in development and commercial programs, ensuring quality standards are consistently met across all operations. Reporting to the Senior Director of Global Quality Assurance, the Director leads both the Quality Operations and Quality Engineering teams. Daily responsibilities include providing direct support for quality-related activities and guiding team efforts to maintain compliance and operational excellence. Location and schedule This role is based at the Northbridge, MA facility. The company offers a hybrid work arrangement, requiring at least three days per week on-site. During major project milestones, on-site presence may be needed more frequently. The position also involves regular travel to the Watertown location, typically one to two times per week. Occasional travel to external partner sites is expected, accounting for approximately 5-10% of the time.

Role overview EyePoint Pharmaceuticals is hiring a Senior Manager of Warehouse Operations to lead GxP warehouse activities at the Northbridge, MA site. This position manages the full cycle of warehouse operations, including the receipt, storage, handling, and distribution of both raw materials and finished goods. The role supports clinical and commercial manufacturing and holds responsibility for maintaining accurate inventory records. Strict compliance with FDA, EMA, GMP, GDP, OSHA, and other relevant regulations is essential. Key responsibilities Direct daily operations in the warehouse, supervising staff and coordinating workflows Oversee inventory management to ensure accuracy and regulatory compliance Maintain and enforce adherence to FDA, EMA, GMP, GDP, OSHA, and related standards Identify and implement improvements to warehouse processes and systems Support initiatives aimed at operational excellence, efficiency, and quality Location and travel This position is fully on-site in Northbridge, MA. Occasional travel to Watertown, MA may be required. Compensation and benefits Competitive compensation package Equity options Comprehensive benefits available from date of hire