Process Engineer
LanceSoft Inc · Posted Nov 10, 2026
- Princeton, New Jersey, United States
- On-site
- 5+ years
Provide technical leadership and support to a cGMP cell therapy manufacturing facility, driving technology transfer, process improvement, and regulatory compliance.
Responsibilities
- Process Subject Matter Expert and process owner for technology transfer and new product introduction
- Perform technology transfer facility, process, workflow, and equipment fit assessment, process gap analysis, and process risk assessment when onboarding new programs
- Author, review, and approve internal cGMP technical documents
- Provide on-the-floor technical support to manufacturing including process execution and troubleshooting, Quality Event triage, root cause analysis, and CAPA implementation
- Compile, trend, analyze, and summarize cGMP manufacturing data using processing trending and statistical analysis tools
Requirements
- Bachelor's in Science or Chem/Bio Engineering
- Advanced degree in Science or Chem/Bio Engineering
- Nice to have: Advanced degree(s)
- Nice to have: Experience with start-up, validation, and licensure of new biopharmaceutical manufacturing facilities
- Nice to have: Experience with program management software and tools