Cell Therapy Process Engineer II — Drive Robust GMP Operations

Kincell Bio; Gainesville (FL); On-site; USD 85,000 - 110,000; Full time

Benefits offered by this job

Competitive benefits

Rewards for performance

Job summary

Kincell Bio in Gainesville, FL is seeking a Process Engineer II to lead complex technical work across interconnected cell therapy unit operations. You will drive investigations, process characterization, technology transfer, and validation activities while supporting cross-functional teams.

The role requires a strong GMP background, hands-on problem solving, and the ability to mentor engineers. Join us to advance clinically meaningful therapies and ensure robust manufacturing processes.

Qualifications

• Bachelor's degree in Engineering, Biology, Biotechnology, Life Sciences, or related with 4+ years of GMP 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.
• Ability to manage multiple priorities and lead cross-functional technical projects with limited supervision.
• Strong technical writing, data analysis, presentation, and client communication skills.

Responsibilities

• Own and lead multiple interconnected unit operations or a complete upstream or downstream process segment.
• Lead complex deviation investigations and root cause analyses using structured tools such as 5-Why, fishbone, fault tree, and risk assessment.
• Plan and lead process characterization, engineering, comparability, and optimization studies using sound experimental design.
• Lead technology transfer execution, including gap assessment, facility fit, equipment fit, process risk assessment, readiness planning, and transfer documentation.
• Develop or lead process validation protocols, reports, acceptance criteria, and supporting risk assessments.
• Apply statistical methods such as DOE, SPC, capability analysis, and multivariate trending to improve process understanding and control.
• Lead cross-functional process improvement initiatives focused on yield, robustness, cycle time, contamination control, and right-first-time performance.
• Assess new equipment, single-use systems, raw materials, and manufacturing technologies and recommend implementation strategies.
• Author and approve technical content in SOPs, MBRs, protocols, reports, Change Controls, and regulatory support documents.
• Represent MSAT in regular client technical meetings and communicate risks, data, decisions, and recovery plans clearly.
• Mentor Associate Process Engineers and Process Engineers I through technical coaching and review of deliverables.
• Support audits, inspections, and program governance as a subject-matter expert for assigned processes.

Skills

Investigations

Technology transfer

Validation

Process improvement

GMP

Cell therapy manufacturing

Aseptic processing

Contamination control

Risk management

Project management

Technical writing

Data analysis

Client communication

Education

Bachelor's degree in Engineering, Biology, Biotechnology, Life Sciences, or a related discipline

Tools

Statistical software

Job description

Kincell Bio in Gainesville, FL is seeking a Process Engineer II to lead complex technical work across interconnected cell therapy unit operations. You will drive investigations, process characterization, technology transfer, and validation activities while supporting cross-functional teams.

The role requires a strong GMP background, hands-on problem solving, and the ability to mentor engineers. Join us to advance clinically meaningful therapies and ensure robust manufacturing processes.