Sr. Quality Validation Engineer-Drug Development
EyePoint
4 hours ago
Remote friendly (Northbridge, MA)
United States
Operations
This Role Is Responsible For
- Quality validation and qualification oversight of drug substance and drug product process development, including test method development and in-process/final release specification development/refinement; guiding teams to define critical processing parameters and critical quality attributes.
- Quality oversight for primary and secondary packaging process validation/qualification in preparation for commercialization.
- Leading cross-functional teams to adhere to validation/qualification documentation lifecycle (e.g., Process Risk Assessments, Change Controls).
- Working with internal stakeholders to review/approve drug product validation and qualification activities and documentation.
- Ensuring consistent approach and that the facility is “inspection ready” and compliant with regulatory requirements and EyePoint procedures/policies.
Primary responsibilities include
- Provide quality engineering and operations expertise to Product R&D (Analytical Development and CMC), Manufacturing, Facilities, and Engineering.
- Ensure quality/compliance systems support product compliance with regulatory and industry expectations; achieve quality by design (process verification/validation, specification/procedure development, risk management, process review).
- Collaborate with external partners on process validation initiatives.
- Use systematic problem-solving to identify, prioritize, communicate, and resolve quality issues.
- Lead/develop/modify validation packages and deliverables (risk assessments such as FMEAs, plans, requirements, protocols).
- Recommend/review processes and test methods to ensure appropriate quality control analysis.
- Participate in risk analysis for quality events (e.g., CAPA, deviations, change controls).
- Drive continuous improvement (validation approach optimization, templates, lifecycle documentation practices).
- Identify and mitigate quality risks across the product lifecycle.
Primary skills and knowledge required
- Pharmaceutical industry experience with small-molecule modalities (combination and/or ophthalmic a plus).
- Experience across clinical development through commercialization/PLCM.
- In-depth knowledge of US and EU cGMP regulations and guidance.
- Ability to collaborate and lead cross-functionally with CMC, Technical Operations, and Quality.
- Cleanroom production experience, including gowning practices, cleanroom behaviors, and aseptic techniques.
- Strong communication and collaboration; motivated problem-solver.
- QMS investigational experience required (Root Cause Analysis).
- Proven ability to influence/build/promote a culture of Quality.
Level of Education Required
- Bachelor of Science in a relevant field (Science/Engineering) or equivalent.
Years of Experience
- 8+ years of cGMP industry experience in drug development, including at least 2 years in a supporting quality role (or equivalent education/experience).
- Quality validation and qualification oversight of drug substance and drug product process development, including test method development and in-process/final release specification development/refinement; guiding teams to define critical processing parameters and critical quality attributes.
- Quality oversight for primary and secondary packaging process validation/qualification in preparation for commercialization.
- Leading cross-functional teams to adhere to validation/qualification documentation lifecycle (e.g., Process Risk Assessments, Change Controls).
- Working with internal stakeholders to review/approve drug product validation and qualification activities and documentation.
- Ensuring consistent approach and that the facility is “inspection ready” and compliant with regulatory requirements and EyePoint procedures/policies.
Primary responsibilities include
- Provide quality engineering and operations expertise to Product R&D (Analytical Development and CMC), Manufacturing, Facilities, and Engineering.
- Ensure quality/compliance systems support product compliance with regulatory and industry expectations; achieve quality by design (process verification/validation, specification/procedure development, risk management, process review).
- Collaborate with external partners on process validation initiatives.
- Use systematic problem-solving to identify, prioritize, communicate, and resolve quality issues.
- Lead/develop/modify validation packages and deliverables (risk assessments such as FMEAs, plans, requirements, protocols).
- Recommend/review processes and test methods to ensure appropriate quality control analysis.
- Participate in risk analysis for quality events (e.g., CAPA, deviations, change controls).
- Drive continuous improvement (validation approach optimization, templates, lifecycle documentation practices).
- Identify and mitigate quality risks across the product lifecycle.
Primary skills and knowledge required
- Pharmaceutical industry experience with small-molecule modalities (combination and/or ophthalmic a plus).
- Experience across clinical development through commercialization/PLCM.
- In-depth knowledge of US and EU cGMP regulations and guidance.
- Ability to collaborate and lead cross-functionally with CMC, Technical Operations, and Quality.
- Cleanroom production experience, including gowning practices, cleanroom behaviors, and aseptic techniques.
- Strong communication and collaboration; motivated problem-solver.
- QMS investigational experience required (Root Cause Analysis).
- Proven ability to influence/build/promote a culture of Quality.
Level of Education Required
- Bachelor of Science in a relevant field (Science/Engineering) or equivalent.
Years of Experience
- 8+ years of cGMP industry experience in drug development, including at least 2 years in a supporting quality role (or equivalent education/experience).