Associate Scientist/Engineer

4 weeks ago


Summit, New Jersey, United States Joulé Full time
Job Summary

We are seeking a highly skilled Associate Scientist/Engineer to join our team at Joulé. As a key member of our scientific team, you will be responsible for conducting thorough investigations, leading cross-functional investigation teams, and closing reports in a timely manner.

Key Responsibilities
  • Conduct root cause analysis to identify and resolve deviations and quality issues
  • Lead investigations and cross-functional teams to close reports and implement corrective actions
  • Perform GEMBA walks to evaluate process steps and identify areas for improvement
  • Develop and implement effective CAPAs and change control documentation
  • Assess potential impact and risk associated with changes and develop mitigation strategies
  • Provide technical support for manufacturing investigations and CAPAs
  • Support deviation investigation defense during audits and site inspections
  • Employ lean manufacturing and six sigma principles to continuously improve products, processes, and systems
Requirements
  • Bachelor's degree in science or engineering, preferably in biochemistry or a related field
  • Minimum 1 year of relevant work experience in a health authority regulated environment
  • Previous experience working in a biopharmaceutical manufacturing facility is preferred
  • Strong technical writing skills and ability to collaborate effectively in cross-functional teams
  • Proven ability to accurately and completely understand and apply Global Regulatory and cGMP requirements
Benefits

Joulé offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, and participation in a 401(k) plan.



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