Pharma Process Engineer — CMC & Process Development

Jobvite, Inc.; Fort Lauderdale, Northern (FL, KY); Hybrid; USD 90,000 - 130,000; Full time

Job summary

Kymanox seeks a Contract Process Engineer to join our CMC & Pharmaceutical Sciences team and lead the design, development, and optimization of manufacturing processes for drug substance and drug product.

You will collaborate with Quality, Operations, Regulatory Affairs, and Supply Chain, ensure cGMP compliance, and oversee validations, tech transfers, and continuous improvement under senior engineers.

Qualifications

• Advanced degree in a science-related field (MS/MEng) in Biomedical, Mechanical, or Chemical Engineering.
• 5+ years of experience in the pharmaceutical or combination products industry.
• Strong knowledge of cGMP and FDA guidance; quality systems.
• Proven ability to develop and document SOPs, batch records, and validation protocols.
• Excellent writing and communication skills.

Responsibilities

• Develop technical documentation for drug substance and drug product manufacturing across multiple modalities.
• Design and develop manufacturing processes from concept to commercial implementation.
• Lead root cause analyses and drive continuous improvement for cost and quality.
• Create and maintain process documentation including flow diagrams, risk assessments, SOPs, batch records, and validation protocols.
• Plan, execute, and oversee IQ/OQ/PQ validation studies and tech transfer with regulatory compliance.
• Evaluate and select equipment, conduct vendor assessments, and oversee installation and integration.
• Ensure processes comply with cGMP and FDA; support regulatory submissions and audits.
• Collaborate with Quality, Operations, Product Development, Regulatory Affairs, and Supply Chain.

Skills

Problem solving

Technical writing

Communication skills

Interpersonal skills

Education

Master's degree in Biomedical Engineering

Tools

MS Office

Job description

Kymanox seeks a Contract Process Engineer to join our CMC & Pharmaceutical Sciences team and lead the design, development, and optimization of manufacturing processes for drug substance and drug product.

You will collaborate with Quality, Operations, Regulatory Affairs, and Supply Chain, ensure cGMP compliance, and oversee validations, tech transfers, and continuous improvement under senior engineers.