Cell Therapy Process Engineer II (GMP)

Kincell Bio, LLC; Gainesville (FL); On-site; USD 95,000 - 125,000; Full time

Job summary

Kincell Bioengineers cells into therapies in Gainesville, FL, seeking a Process Engineer II to lead complex unit operations and drive process robustness. This role supports manufacturing, quality, and clients within a GMP CDMO setting, with emphasis on investigations, validation, and tech transfer.

The position requires a BS in a related field and 4+ years of experience, strong technical writing, data analysis, and ability to collaborate across cross-functional teams.

Qualifications

• Bachelor's degree and 4+ years in GMP-related cell therapy manufacturing or equivalent.
• Experience leading investigations, engineering studies, tech transfer, validation, or process improvement.
• Strong writing, data analysis, presentation, and client communication skills.

Responsibilities

• Provide technical ownership for multiple interconnected unit operations or a complete upstream or downstream process segment.
• Lead 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 sound experimental design.
• Lead technology transfer, including gap assessment, facility and equipment fit, risk assessment and transfer documentation.
• Develop or lead process validation protocols, reports, acceptance criteria, and risk assessments.
• Apply DOE, SPC and multivariate analysis to improve process understanding and control.
• Mentor junior engineers and support audits, inspections, and governance as SME.

Skills

GMP experience

Cell therapy

Process optimization

DOE

Technical writing

Education

Bachelor's degree in Engineering/Biology/Biotechnology/Life Sciences

Tools

Statistical software

Process characterization tools

Job description

Kincell Bioengineers cells into therapies in Gainesville, FL, seeking a Process Engineer II to lead complex unit operations and drive process robustness. This role supports manufacturing, quality, and clients within a GMP CDMO setting, with emphasis on investigations, validation, and tech transfer.

The position requires a BS in a related field and 4+ years of experience, strong technical writing, data analysis, and ability to collaborate across cross-functional teams.