Manufacturing Process Specialist

18 hours ago


Princeton, New Jersey, United States Disability Solutions Full time

About the Role:

Catalent Pharma Solutions in Princeton, NJ is hiring a Manufacturing Science and Technology (MSAT) Process Engineer who provides technical support to manufacturing processes in a GMP environment. This role involves troubleshooting process and equipment-related issues that occur during the manufacturing process. The MSAT Process Engineer works closely with the Manufacturing and Quality teams to determine immediate corrective actions for deviations, identifies root cause, and implements long-term preventive actions.

Responsibilities:

  • Provide on-the-floor and on-site technical support to manufacturing when necessary;
  • Author, review and approve various documents (batch records, SOPs);
  • Analyze and summarize manufacturing data to support impact assessments and investigations;
  • Owner of change controls for process and procedure changes; Lead and executes CAPA system investigations;
  • Leads technology transfer efforts for new processes and product implementation.

About the Team:

The successful candidate will join our dynamic team of experts in the field of biotechnology and pharmaceutical manufacturing. As a key member of the MSAT team, you will have the opportunity to work on challenging projects and contribute to the development of new technologies and processes.

Requirements:

  • Bachelors and/or Advanced degree required in Science or Chemical/Biological Engineering with 5+ years of industry experience required;
  • 3+ years relevant experience in GMP biologic/cell therapy manufacturing technical or process support;
  • Scientific understanding in bioprocessing principles and familiarity with cell therapy processes and cGMP is strongly preferred;
  • Experience in process qualification and validation required;
  • Estimated salary: $120,000 - $150,000 per year.


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