Production Engineer - API Manufacturing & Process Excellence

Cambrex Corp.; Charles City (IA); On-site; USD 55,000 - 75,000; Full time

Job summary

Cambrex Corp. in Iowa is seeking a Production Engineer to act as an operations technical expert, reviewing documentation and implementing projects for API and bulk intermediate manufacture from development through piloting to commercial production.

You will write batch records, initiate SOPs and CAPAs, review operations documentation, and troubleshoot equipment while coordinating with maintenance to improve efficiency. Rigorous adherence to cGMP is expected.

Qualifications

• Experience in a cGMP environment preferred.
• Knowledge of chemical operations equipment and manufacturing processes.

Responsibilities

• Writing batch records and cleaning records for commercial products or simple revisions, campaign reports as needed.
• Initiate SOPs and investigations/deviation reports/CAPAs for production operations and commercial products.
• Reviewing and approving documentation (batch records, cleaning records, supplements, etc) for Operations as the area technical expert.
• Troubleshoot equipment and coordinate with maintenance to monitor equipment for efficiency improvement.
• Assist Process Engineers and Chemical Development teams when new processes are transferred into the area workcenter.
• Work with Validation Engineering and Maintenance departments on developing and maintaining IQ, OQ and PQ documents and protocols.
• Ownership of equipment and facility change controls in their assigned area workcenter.
• Generate product setups and cleaning memos as needed.
• Troubleshooting, investigating process problems and deviations, and preparing appropriate reports on findings.
• Participating in HAZOPs and providing guidance on corrective actions when needed.
• Completing CAPAs and audit action items as assigned.
• Train Operators or Technicians on equipment and process operations as needed to ensure safe and efficient manufacturing.

Skills

cGMP knowledge

chemical operations equipment

Education

BS in Chemical Engineering

Job description

Cambrex Corp. in Iowa is seeking a Production Engineer to act as an operations technical expert, reviewing documentation and implementing projects for API and bulk intermediate manufacture from development through piloting to commercial production.

You will write batch records, initiate SOPs and CAPAs, review operations documentation, and troubleshoot equipment while coordinating with maintenance to improve efficiency. Rigorous adherence to cGMP is expected.