Senior​/Quality Engineer

EyePoint is a patient‑centric, award‑winning ophthalmology company dedicated to preventing blindness through vision‑saving medications, proprietary pharmaceutical technologies, and transformative ocular drug delivery.

• Preventing blindness through vision‑saving medications
• Delivering best‑in‑class proprietary pharmaceutical technologies
• Transforming ocular drug delivery

EyePoint offers robust total rewards in a science‑based entrepreneurial culture that empowers curiosity and innovation to help catapult your career.

This role reports directly to the Director of Quality Engineering and provides quality engineering oversight of drug product validation and qualification at the Northbridge, MA facility, which manufactures, packages, and tests late‑stage clinical and commercial products for EyePoint.

• Quality oversight of the validation and qualification drug product process development for testing, manufacturing, packaging, and associated equipment, including lifecycle documentation (i.e., Process Risk Assessments).
• Working with internal stakeholders on the review and approval of drug product–associated validation and qualification activities and documentation.
• Ensuring consistency of approach and guaranteeing the facility is inspection‑ready and compliant with regulatory requirements and EyePoint procedures and policies.
• Serve as a team member to provide quality engineering expertise to Product R&D, Manufacturing Operations, Facilities, and Engineering departments.
• Maintain company compliance with in‑house and/or external specifications and standards (i.e., GxP, ISO, ANSI, etc.).
• Partner with Development and Engineering departments to ensure drug process development requirements are met effectively to achieve quality by design, including process verification, validation, specification and procedure development, risk management, and process review.
• Apply sound, systematic problem‑solving methodologies to identify, prioritize, communicate, and resolve quality issues.
• Identify areas for process improvement and provide supporting information for change, including reasons and justification.
• Collaborate in the development or modification of validation packages and deliverables, including assessments (i.e., risk assessments, FMEAs), plans, requirements, and protocols.
• Act as a subject matter expert on Risk Management, Test Method Validation (TMV), Statistics, Reliability Engineering, and Process Validation (PV).
• Participate in or lead teams in supporting quality disciplines, decisions, and practices (e.g., represent the Quality function as a Core Team Member).
• Recommend and review processes and tests to determine that appropriate quality control analysis is being performed.
• Support projects and organizational initiatives as identified by management, including line clearance and production inspection.
• Participate in risk analysis associated with but not limited to Corrective and Preventive Action (CAPA), Change Control, complaint investigation, failure investigation, and hazard assessment processes.
• Execute and review data analysis, process capability assessments, sampling plans, and statistical evaluations for validation outcomes.
• Maintain the validated state of systems through periodic review and requalification programs.
• Contribute to continuous improvement initiatives, including optimization of validation approaches, templates, and lifecycle documentation practices.
• All other duties as assigned.

• Experience in the pharmaceutical industry; experience in process/equipment qualifications;
  Medical Device / Combination Products a plus.
• Maintains current knowledge of global regulatory agency trends and drives implementation of related improvements throughout Operations and R&D work groups.
• Has wide‑ranging experience and is able to use Quality concepts and company objectives to resolve complex issues effectively.
• Extensive knowledge of US and EU cGMP regulations and guidance.
• Proactively seeks to affect change to provide an inspection readiness state and reduce the number of observations identified during audits/inspections conducted.
• Oversees creation and…