Process Engineer
2 days ago
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.
- 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.
- 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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