Senior Process Engineer - Pharma Manufacturing & Transfer

Kymanox; United States; On-site; USD 90,000 - 130,000; Full time

Job summary

A leading pharmaceutical firm in the United States is seeking a Senior Process Engineer to lead design and optimization of manufacturing processes. The ideal candidate will have over 10 years of experience in the pharmaceutical industry, strong regulatory and quality assurance knowledge, and a Master's degree in a science-related field. Responsibilities include developing technical documentation, process validation, and continuous improvement initiatives. The position may require up to 10% travel for events.

Qualifications

• 10+ years of experience in the pharmaceutical or combination products industry.
• Demonstrated expertise in drug substance and drug product process development.
• Strong knowledge of cGMP regulations and FDA guidance documents.

Responsibilities

• Develop technical documentation for drug substance and drug product manufacturing.
• Design and develop manufacturing processes from concept to implementation.
• Lead root cause analysis and implement continuous improvement initiatives.
• Plan, execute, and oversee process validation studies.
• Ensure compliance with cGMP and FDA regulations.

Skills

Process engineering principles

Regulatory compliance

Quality assurance

Technical writing

Analytical thinking

Excellent communication

MS Office proficiency

Education

Master of Science or Master of Engineering in a science-related field

Job description

A leading pharmaceutical firm in the United States is seeking a Senior Process Engineer to lead design and optimization of manufacturing processes. The ideal candidate will have over 10 years of experience in the pharmaceutical industry, strong regulatory and quality assurance knowledge, and a Master's degree in a science-related field. Responsibilities include developing technical documentation, process validation, and continuous improvement initiatives. The position may require up to 10% travel for events.