Senior/Quality Engineer

Be Seen and Heard at EyePoint

At EyePoint, leadership trusts our employees to get the job done. The patient-centric and award-winning approach we’re taking in business fuels our success for:

• preventing blindness through vision-saving medications
• delivering best-in-class proprietary pharmaceutical technologies
• transforming ocular drug delivery

We See You.

• Your wellbeing
• Your professional worth
• Your future at EyePoint

EyePoint offers robust total rewards in a science-based entrepreneurial culture that empowers curiosity and innovation to help catapult your career. There’s space for every voice and perspective to be heard in our on-site and remote environments where a variety of strengths and diverse backgrounds are connected.

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.

This role is responsible for:

• 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.

Primary responsibilities include, but are not limited to, the following:

Individual Responsibilities

• 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
• Identifies areas for process improvement and provides supporting information for change, including reasons and justification.
• Collaborates 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 ass activities as required including but not limited to line clearance and production inspection.
• Participate in risk analysis associated with but not limited to Corrective and Preventative 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

Primary skills and knowledge required include, but are not limited to the following:

• 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 Quality organization and serves as a technical/regulatory resource for R&D and QC.
• Strong technical expertise of QA/QC and Manufacturing processes to facilitate development and maintenance of cGMP compliant quality systems.
• Actively promotes safety rules and awareness. Demonstrates sound safety practices at all times including appropriate use of protective equipment.  Reports and takes initiative to correct safety and environmental hazards
• Provides consistently prompt, efficient, dependable, highly skilled service
• Demonstrates consistent judgment, quality, accuracy, speed, and creativity
• Detects and resolves problems; assists others with problem resolution; misjudgment may jeopardize compliance.
• Takes initiative in making improvement suggestions to promote operational goals on a consistent basis.
• Active team member with broad exposure within as well as outside of company
• Recommend improvements to on-going processes and projects
• Facilitates designing processes with Quality built in from the beginning. Handles most out-of-compliance situations.
• High level of professional competence
• ASQ (American Society for Quality) and/or ISO certification as a Certified Quality Engineer preferred
• Experience with production of pharmaceutical products in an ISO7 cleanroom environment including knowledge of gowning practices, cleanroom behaviors and aseptic techniques.
•  Knowledge of cGMP regulations and FDA guidance applicable to drug product manufacturing.
•  Previous experience working with medical device packaging and microscope assembly work.
•  Strong communication skills, collaborative teammate, motivated and passionate about finding solutions.
• Strong awareness of quality issues. Compliance investigation experience preferred.

Level of Education Required:

• Bachelor of Science in relevant field (Science /Engineering)
• On the job experience will be considered in lieu of education requirements.

Number of Years of Experience in the Function and in the Industry:

• 3 - 7 years of cGMP experience required; Quality Engineering roles strongly preferred.

Envision Your Future

With the exciting energy of a winning culture and an exhilarating pace, we are an ophthalmology company committed to preventing blindness by developing and commercializing innovative therapeutics.

The collective power of our values influences everything we do, and everything we do for you.

EyePoint is proud to be an equal opportunity employer. We believe that diversity and inclusion among our colleagues is critical to our success as a company, and we seek to recruit, develop, and retain the most talented people from a diverse candidate pool. All applicants will be considered for employment without attention to age, race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or disability status.

EyePoint is committed to fair and equitable compensation practices. The salary offer is commensurate with EyePoint’s compensation philosophy and considers factors including but not limited to education, training, experience, market conditions, criticality of the role and internal equity.

The target salary range for this position is listed below.

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