Pharma API Production Engineer: Operations Expert

Cambrex; Charles City (IA); On-site; USD 65,000 - 90,000; Full time

Job summary

Cambrex is seeking a Production Engineer in Charles City, IA to serve as the operations technical expert for manufacturing APIs, bulk intermediates, and related products from development through piloting to commercial production.

You will write batch/cleaning records, initiate SOPs and CAPAs, review documentation, and troubleshoot equipment with maintenance. Collaboration with Process Engineers and Development teams is essential for successful process transfers and change controls.

Qualifications

• Knowledge of and/or direct experience in a cGMP environment.
• General knowledge of chemical operations equipment and manufacturing operations.
• BS in Chemical Engineering or similar field, plus 1 – 3 years of experience in manufacturing environment, preferably in pharmaceutical manufacture; or equivalent education/experience.

Responsibilities

• Write batch records and cleaning records for commercial products or revisions, campaign reports as needed.
• Initiate SOPs and investigations/deviation reports/CAPAs for production operations.
• 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 IQ, OQ and PQ documents and protocols. Ownership of equipment and facility change controls.
• 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.
• Additional job duties as assigned.

Skills

cGMP knowledge

Chemical operations knowledge

Documentation writing

Education

BS in Chemical Engineering or similar field

1–3 years manufacturing/pharmaceutical experience

Job description

Cambrex is seeking a Production Engineer in Charles City, IA to serve as the operations technical expert for manufacturing APIs, bulk intermediates, and related products from development through piloting to commercial production.

You will write batch/cleaning records, initiate SOPs and CAPAs, review documentation, and troubleshoot equipment with maintenance. Collaboration with Process Engineers and Development teams is essential for successful process transfers and change controls.