Senior Process Engineer — Pharmaceutical Manufacturing Leader

Kymanox; United States; On-site; USD 140,000 - 180,000; Full time

Job summary

Kymanox is seeking a Senior Process Engineer to lead the design, development, and optimization of manufacturing processes for pharmaceutical substances and products. The role encompasses regulatory compliance, quality systems, and strong technical leadership across cross-functional teams.

You will develop technical documentation, plan validation studies, technology transfer, and drive continuous improvements while collaborating with Quality, Operations, and Regulatory Affairs.

Qualifications

• Advanced degree in a science-related field (e.g., MS/ME) is required.
• 10+ years of experience in the pharmaceutical or related industry.
• Strong knowledge of cGMP, FDA guidance, and quality systems.
• Excellent technical writing and documentation skills (SOPs, batch records, validation protocols).
• Ability to work cross-functionally with Quality, Operations, and Regulatory Affairs.
• Experience with process development, optimization, and technology transfer.

Responsibilities

• Develop manufacturing processes from concept to commercial implementation per regulatory guidelines.
• Create and maintain process documentation including flow diagrams, risk assessments, SOPs, and validation plans.
• Lead root-cause analyses and continuous improvement initiatives to enhance efficiency and quality.
• Plan, execute, and oversee IQ/OQ/PQ validation studies and technology transfer activities.
• Evaluate equipment, conduct vendor assessments, and manage installation and integration in production.
• Ensure compliance with cGMP, FDA regulations, and audit readiness.

Skills

Process engineering

Regulatory compliance

Technical writing

Cross-functional collaboration

Problem solving

Education

Master of Science in Biomedical/Mechanical/Chemical Engineering

Tools

MS Office

Job description

Kymanox is seeking a Senior Process Engineer to lead the design, development, and optimization of manufacturing processes for pharmaceutical substances and products. The role encompasses regulatory compliance, quality systems, and strong technical leadership across cross-functional teams.

You will develop technical documentation, plan validation studies, technology transfer, and drive continuous improvements while collaborating with Quality, Operations, and Regulatory Affairs.