Process Engineer II – Cell Therapy & Tech Transfer

Kincell Bio, LLC; Gainesville (FL); On-site; USD 90,000 - 130,000; Full time

Job summary

Kincell Bio, LLC in Gainesville, FL is seeking a Process Engineer II to lead technical work across unit operations in cell therapy manufacturing. The role drives investigations, characterization, technology transfer, validation, and cross-functional improvements while serving as a technical resource to Manufacturing, Quality, and clients.

The successful candidate will apply DOE, SPC, and risk assessments to improve process understanding, robustness, and transfer readiness.

Qualifications

• Bachelor's degree in Engineering, Biology, Biotechnology, Life Sciences, or a related discipline with 4+ years of relevant experience.
• Experience leading investigations, engineering studies, technology transfer, validation, or process improvement in a GMP environment.
• Strong understanding of cell therapy manufacturing, aseptic processing, contamination control, and process risk management.

Responsibilities

• Provide technical ownership for multiple interconnected unit operations or a complete upstream or downstream process segment.
• Lead complex deviation investigations and root cause analyses using structured tools (5-Why, fishbone, fault tree).
• Plan and lead process characterization, engineering, comparability, and optimization studies with solid experimental design.

Skills

Process engineering

Root cause analysis

Statistical methods (DOE/SPC)

Education

Bachelor's degree in Engineering or Life Sciences

Tools

MS Excel

DOE software

Job description

Kincell Bio, LLC in Gainesville, FL is seeking a Process Engineer II to lead technical work across unit operations in cell therapy manufacturing. The role drives investigations, characterization, technology transfer, validation, and cross-functional improvements while serving as a technical resource to Manufacturing, Quality, and clients.

The successful candidate will apply DOE, SPC, and risk assessments to improve process understanding, robustness, and transfer readiness.