Sr. Quality Validation Engineer-Drug Development

Location: Northbridge, MA

Department: Quality

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