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Senior Quality Validation Engineer - Drug Development

Hybrid Full-time $142.1K/yr - $179.2K/yr

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Experience Level

Senior

Qualifications

To excel in this role, candidates should possess:A Bachelor's degree in a relevant field (e.g., Engineering, Life Sciences). Strong knowledge of quality validation principles and regulatory requirements in drug development. Proven experience in quality engineering within the pharmaceutical or biotechnology industries. Exceptional analytical skills and a detail-oriented approach. Excellent communication skills for effective collaboration across departments.

About the job

As a Senior Quality Validation Engineer at EyePoint Pharmaceuticals, you will play a pivotal role in ensuring the quality and compliance of our drug development processes. Reporting directly to the Director of Quality Engineering, you will contribute to both the development and validation of drug substances and drug products.

This position offers a hybrid work schedule, promoting a balance between in-office collaboration and remote work flexibility.

Key Responsibilities:

  • Oversee quality validation and qualification processes related to drug substance and product development, including the creation and refinement of test methods and specifications.
  • Ensure quality oversight for packaging processes as we prepare for commercialization.
  • Lead cross-functional teams in maintaining validation documentation throughout its lifecycle, including Process Risk Assessments and Change Controls.

Additionally, you will:

  • Collaborate with internal stakeholders to review and approve validation and qualification documentation related to drug products.
  • Ensure our facility remains compliant with regulatory requirements and is always inspection-ready, adhering to EyePoint's procedures and policies.

Primary Responsibilities:

  • Provide quality engineering expertise to the Research and Development, Manufacturing, Facilities, and Engineering teams.
  • Establish and maintain quality and compliance systems that align with industry and regulatory standards.
  • Work closely with Development and Engineering teams to ensure effective implementation of drug process development requirements.
  • Engage with external partners on process validation initiatives.
  • Utilize systematic problem-solving methodologies to identify and resolve quality issues.
  • Lead the development and modification of validation packages, including risk assessments and validation protocols.
  • Review processes and test methods to ensure robust quality control analysis.
  • Participate in risk analysis related to Quality events such as CAPA and deviations.
  • Contribute to continuous improvement initiatives.

About EyePoint Pharmaceuticals

EyePoint Pharmaceuticals is dedicated to advancing innovative drug delivery solutions to improve patient outcomes. Our mission is to enhance the therapeutic efficacy of existing treatments and address unmet medical needs through our proprietary technologies.

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