Production Engineer, API Manufacturing & Optimization

Cambrex Corp.; Charles City, Northern (IA, KY); Hybrid; USD 65,000 - 85,000; Full time

Job summary

Cambrex Corp. in Charles City, IA, is seeking a Production Engineer to serve as an operations technical expert for API and bulk intermediate manufacturing from development through piloting and commercial production.

You will write batch records, initiate SOPs, review docs, troubleshoot equipment, support process transfers, and maintain IQ/OQ/PQ protocols while ensuring cGMP compliance and safety. BS in Chemical Engineering with 1–3 years in manufacturing preferred; knowledge of cGMP and chemical

Qualifications

• cGMP familiarity and related regulatory awareness.
• General knowledge of chemical operations equipment and manufacturing processes.

Responsibilities

• Write batch and cleaning records for commercial products and revisions as needed.
• Initiate SOPs, investigations, deviations, and CAPAs for production operations and products.
• Review and approve documentation for Operations with technical expertise.
• Troubleshoot equipment and coordinate with maintenance for efficiency improvements.
• Assist process engineers and development teams with new process transfers.

Education

BS in Chemical Engineering

1–3 years manufacturing experience

Tools

cGMP knowledge

Equipment knowledge

Job description

Cambrex Corp. in Charles City, IA, is seeking a Production Engineer to serve as an operations technical expert for API and bulk intermediate manufacturing from development through piloting and commercial production.

You will write batch records, initiate SOPs, review docs, troubleshoot equipment, support process transfers, and maintain IQ/OQ/PQ protocols while ensuring cGMP compliance and safety. BS in Chemical Engineering with 1–3 years in manufacturing preferred; knowledge of cGMP and chemical