Process Engineer

2 days ago


Madison WI USA, United States Catalent Inc Full time
Job Title: Process Engineer - Manufacturing Sciences & Technology

Catalent is a global leader in the development and manufacturing of new treatments for patients worldwide. We are seeking a highly skilled Process Engineer to join our Manufacturing Sciences & Technology team in Downstream.

About the Role:
  • Support technology transfer of processes into manufacturing for both internally and externally developed processes.
  • Oversee technical support of Manufacturing, including the technology transfer between external clients or Process Development and Manufacturing.
  • Work alongside a group of engineers, scientists, and other colleagues to drive the facility fit and technical transfer of biologic processes.
  • Perform responsibilities associated with the evaluation, alignment, and recommendation of equipment and process improvements.
  • Works closely with manufacturing to author appropriate batch documentation and provide technical and strategic oversight associated with GMP manufacturing.
  • Leads and/or supports the compilation of process data, including communicating project status, trend identification, and delivering internal or client presentations.
  • Evaluates existing processes and identifies process or equipment improvements to advance efficiency, consistency, and competitiveness within the market.
  • Authors and reviews documents including batch production records, tech transfer reports, bill of materials, process descriptions, project reports, engineering specifications and summary reports.
  • Acts as the lead for technical support of risk assessments, gap analysis, deviations, change controls, and CAPAs including determination of product or process impact, root-cause analysis, and corrective action identification.
Requirements:
  • Associate's degree in a STEM discipline and 6+ years of related experience, OR
  • Bachelor's degree in a STEM discipline with 3+ years of related experience, OR
  • Master's degree in a STEM discipline with 0+ years of related experience
  • Experience in investigating and closing deviations, OOS, and CAPAs preferred.
  • Experience drafting and revising standard operating procedures, batch production records and reports preferred.
  • Experience working on late phase, process performance qualification and commercial programs is a plus.
  • Downstream experience (e.g., depth filtration/clarification, chromatography, tangential flow filtration, viral filtration, BDS fill, etc.) manufacturing processes across cGMP biologics production scales required.
  • Experience in facility fit, process scaling and technology transfer preferred.
Why Catalent:
  • Defined career path and annual performance review and feedback process
  • Diverse, inclusive culture
  • Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives
  • 152 hours of paid time off annually + 8 paid holidays
  • Competitive salary with yearly bonus potential
  • Community engagement and green initiatives
  • Generous 401K match
  • Medical, dental and vision benefits effective day one of employment
  • Tuition Reimbursement

Catalent is an Equal Opportunity Employer, including disability and veterans. If you require reasonable accommodation for any part of the application or hiring process due to a disability, please submit your request by sending an email to .


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