Senior​/Quality Engineer

Senior/Quality Engineer – EyePoint – Northbridge, MA

This person will report directly to the Director, Quality Engineering (QE) and will be responsible for the QE oversight of drug product validation and associated qualifications at the Northbridge, MA facility, which will manufacture, package and test late stage clinical and commercial products for EyePoint.

We offer a hybrid work schedule.

• Quality oversight of the validation and qualification drug product process development for the testing, manufacturing and packaging processes and associated equipment including associated lifecycle documentation (i.e. Process Risk Assessments).
• Working with internal stakeholders on the review / approval of drug product associated validation and qualification activities and documentation.
• Ensuring consistency of approach and ensuring the facility is “inspection ready” / in compliance with the regulatory requirements and EyePoint procedures and policies.
• Serve as a team member to provide quality engineering expertise to product Research and Development, Manufacturing Operations, Facilities, and Engineering departments.
• Maintain company compliance to in-house and/or external specifications and standards (i.e. GxP, ISO, ANSI, etc…)
• Partner with Development and Engineering departments and ensure that drug process development requirements are being met in an effective manner to achieve quality by design, including those for process verification, validation, specification and procedure development, risk management, and process review.
• Apply sound, systematic problem‑solving methodologies in identifying, prioritizing, communicating, and resolving 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 (including risk assessments, e.g., FMEAs), plans, requirements, and protocols.
• Act as a subject matter expert on Risk Management, Test Method Validation (TMV), Statistics, Reliability Engineering, 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 Quality activities (e.g., 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, Medical Device / Combination Products a plus. Experience in process / equipment qualifications.
• Maintains current knowledge of global regulatory agency trends and drives implementation of related improvements throughout Operations and R&D work groups. Maintains current expertise in all related external regulatory requirements, technology, and internal systems, processes and procedures.
• Has wide ranging experience and is able to use Quality concepts and company objectives to resolve complex issues in an effective manner.
• 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 the creation and maintenance of compliance metrics, development of trend data of audit/inspection observations and communication of results expediently to applicable groups.
• Collaborate with the Manufacturing…