Senior Quality Assurance Engineer

3 weeks ago


Petersburg, United States PSC Biotech Full time
Job Overview

PSC Biotech is a leading provider of life sciences services, dedicated to ensuring the highest standards in healthcare product development, manufacturing, and distribution. As a senior quality assurance engineer, you will play a critical role in supporting the commissioning, qualification, and validation program for our new pharmaceutical facility.


Salary Information

We offer an attractive salary range of $120,000 - $180,000 per year, commensurate with experience, as well as a comprehensive benefits package that includes medical, dental, and vision insurance, 401(k) matching, and education assistance.


About the Role

This position requires a strong background in quality engineering and experience with facility start-ups, as well as advanced knowledge of GMP environments and industry best practices. You will be responsible for ensuring the quality and reliability of our facilities, utilities, and process equipment through testing, validation, and quality assurance processes.


Key Responsibilities:
  • Complete quality reviews for CQV documentation for new pharmaceutical facilities.
  • Support the CQV program and operational readiness on new utilities and process equipment.
  • Provide 'on the floor' quality engineering during validation executions.
  • Conduct risk assessments and manage quality risks using tools like FMEA to ensure safety, reliability, and compliance with relevant industry standards and regulations.
  • Perform thorough analysis and interpretation of test results, identifying deviations, anomalies, and areas for improvement, and provide recommendations for corrective actions.
  • Define validation requirements, including test objectives, scope, methodologies, and acceptance criteria, based on project specifications and customer requirements.
  • Collaborate with cross-functional teams to ensure effective communication and alignment of validation efforts.
  • Stay up-to-date with emerging trends, technologies, and best practices in validation engineering and quality assurance, and proactively apply this knowledge to enhance validation processes and methodologies.


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