Bioengineer

Required Skills & Experience

• 5+ years of experience in a cGTP/cGMP-regulated environment
• Hands-on experience with stem cell culture techniques
• Bachelor’s or Master’s degree in Bioengineering, Biomedical Engineering, Cell Biology, or a related scientific field

Nice to Have Skills & Experience

• Experience taking at least one product from concept through FDA 510(k) clearance or Biologics License Application (BLA) approval

Job Description

Insight Global is looking to hire a Bioengineer in Pompano Beach, Florida. This individual will lead bioengineering projects focused on the development and optimization of human cell and tissue products, with an emphasis on stem cells and exosomes. Responsibilities include developing and validating cell culture and cryopreservation processes, designing and executing viability, potency, and characterization testing, and maintaining cGTP/cGMP requirements in laboratory and cleanroom environments. The Bioengineer will create and maintain SOPs, validation plans, process records, and batch documentation while supporting internal and external audits. This individual will also lead product development from initial concept through FDA submission and approval, including 510(k) or BLA pathways, and support technology transfer and scale-up across Quality, Operations, and Clinical teams. This is a 9 month contract-to-hire opportunity with converting salary ranging from $85,000 to $120,000 annually.