Process Engineer - Pharma Manufacturing & Tech Transfer

engineeringjobs.net, Inc.; Fort Lauderdale (FL); On-site; USD 110,000 - 150,000; Full time

Job summary

Kymanox is seeking a Contract Process Engineer in Fort Lauderdale, FL to lead the design, development, and optimization of pharmaceutical manufacturing processes across multiple modalities. The role emphasizes regulatory compliance, QA, and technical leadership to drive continuous improvements.

You will collaborate with Quality, Operations, Regulatory Affairs and other teams, delivering robust process documentation, validation studies, and technology transfer while maintaining audit readiness

Qualifications

• Advanced degree in a science-related field (MS/MEng) required.
• 5+ years in pharmaceutical or combination products industries.
• Strong knowledge of cGMP, FDA guidance, and quality systems.
• Excellent technical writing and documentation skills; ability to develop SOPs, batch records, and CMC content.
• Strong problem-solving and cross-functional collaboration abilities.

Responsibilities

• Develop manufacturing processes from concept through commercial implementation per regulatory guidelines.
• Lead root cause analysis and continuous improvement to enhance efficiency and quality.
• Create and maintain process documentation including flow diagrams, SOPs, and validation protocols.
• Plan, execute, and oversee IQ/OQ/PQ validation studies and technology transfer activities.
• Evaluate equipment, conduct vendor assessments, and manage equipment installation and integration.
• Ensure processes comply with cGMP and FDA regulations; support regulatory submissions and audits.
• Partner with Quality, Operations, Product Development, Regulatory Affairs, and Supply Chain to ensure smooth execution.

Skills

Process engineering

Technical writing

Cross-functional collaboration

Regulatory awareness

Analytical thinking

Education

Advanced degree in Biomedical/Mechanical/Chemical Engineering

Tools

MS Office

Job description

Kymanox is seeking a Contract Process Engineer in Fort Lauderdale, FL to lead the design, development, and optimization of pharmaceutical manufacturing processes across multiple modalities. The role emphasizes regulatory compliance, QA, and technical leadership to drive continuous improvements.

You will collaborate with Quality, Operations, Regulatory Affairs and other teams, delivering robust process documentation, validation studies, and technology transfer while maintaining audit readiness