Product Development Engineer – FDA-Regulated Pharma

Katalyst CRO; El Paso (TX); On-site; USD 120,000 - 180,000; Full time

Job summary

Katalyst CRO is seeking a Product Development Engineer to advance pharmaceutical product development from pilot to commercial scale in a fast-paced, FDA-regulated environment.

The role emphasizes design control, data analysis, and cross-functional collaboration, requiring a BS in Engineering and 12 years of industry experience. You will contribute to DHF/DFMEA, process development, and validation activities while upholding quality and safety standards.

Qualifications

• BS in Engineering with focus on mechanical or biomedical fields.
• Strong analytical and problem-solving abilities in a regulated environment.
• Experience with design control processes and documentation.
• Proven capability to scale from pilot to commercial production.
• Familiarity with quality systems and FDA/ISO standards.

Responsibilities

• Execute product development tasks within quality and design control processes.
• Support equipment qualification, testing, and data analysis.
• Develop and validate test methods for materials and processes.
• Maintain DHF/DFMEA documentation and generate technical reports.
• Participate in design reviews and technology transfers.

Skills

BS in Engineering

Root cause analysis

Statistical methods

FDA regulations knowledge

Cross-functional teamwork

Problem solving

Adaptability

Communication skills

Quality systems

12 years pharma experience

Education

BS degree in Engineering

Tools

Minitab

Excel

Job description

Katalyst CRO is seeking a Product Development Engineer to advance pharmaceutical product development from pilot to commercial scale in a fast-paced, FDA-regulated environment.

The role emphasizes design control, data analysis, and cross-functional collaboration, requiring a BS in Engineering and 12 years of industry experience. You will contribute to DHF/DFMEA, process development, and validation activities while upholding quality and safety standards.