Sr. Quality Validation Engineer-Drug Development

This person will report directly to the Director, Quality Engineering (QE).

We offer a hybrid work schedule.

This Role Is Responsible For

Quality validation and qualification oversight of drug substance and drug product processes development including test method development, in-process and final release specification development/refinement, and guiding teams to define critical processing parameters and critical quality attributes.
Proving Quality oversight for primary and secondary packaging processes validation/qualification in preparation for commercialization.
Leading cross-functional teams in adhering to validation and qualification documentation lifecycle (i.e., Process Risk Assessments, Change Controls, etc.).
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 and operations expertise to product Research and Development (Analytical Development and CMC), Manufacturing, Facilities, and Engineering departments.
Ensure quality and compliance systems are in place to maintain product compliance with current industry and regulatory expectations 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.
Collaborate with external partners on process validation initiatives
Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
Leads and collaborates in the development or modification of validation packages and deliverables, including assessments (including risk assessments, e.g., FMEAs), plans, requirements, and protocols.
Recommend and review processes and test methods to determine that appropriate quality control analysis is being performed.
Participate in risk analysis associated with Quality events (e.g., CAPA, deviation, change control)
Contribute to continuous improvement initiatives, including optimization of validation approaches, templates, and lifecycle documentation practices.
Identify Quality risks and areas for improvement across all stages of the product lifecycle. Partner with stakeholders to mitigate risks and implement associated remediation activities.

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

Experience in the pharmaceutical industry with small molecule drug modalities, with combination and/or ophthalmic products a plus.
Experience with all stages of clinical product development to commercialization product life cycle management.
In-depth knowledge of US and EU cGMP regulations and guidance.
Ability to collaborate and lead cross functionally with CMC, Technical Operations and Quality.
Experience with production of pharmaceutical products in a cleanroom environment including knowledge of gowning practices, cleanroom behaviors and aseptic techniques.
Strong communication skills, collaborative teammate, motivated and passionate about finding solutions.
Strong awareness of quality issues. QMS investigational experience required (Root Cause Analysis).
Possess excellent communication skills and proven track record for influencing/building/promoting a culture of Quality

Level Of Education Required

Bachelor of Science in relevant field (Science /Engineering), or equivalent degree

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

8+ years of cGMP industry experience in drug development and at least 2 years in a supporting quality role, or the equivalent combination of education and experience

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:

Salary Range

$142,140—$179,220 USD

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.

Transformational Innovation

We exist to change our patients’ lives through the power of sight. We are forward looking, embrace challenges with curiosity, and continuously seek to improve our products and ourselves by learning, problem-solving and pushing the limits of science and technology.

Unwavering Integrity

We recognize our responsibility to our patients, employees, and our community, and value the trust they put in us. We set a high ethical bar and expect responsible leadership at every level to ensure we serve those who matter most to us.

Compassionate Excellence

We believe that fun and excellence can coexist. We foster a culture where enjoying the work we do and caring for each other are as important as delivering exceptional outcomes.

Inclusive Collaboration

We strive to see through the eyes of others and work as one team. We appreciate one another’s differences and perspectives, and ensure everyone feels valued, respected and encouraged to bring their ideas forward.

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.
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