Pharma Production Engineer: Batch & Process Optimizer

Cambrex - Charles City

Charles City (IA)

On-site

USD 65,000 - 90,000

Full time

3 days ago

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Job summary

Cambrex - Charles City in Charles City, IA is seeking a Production Engineer as the operations technical expert to support API and bulk intermediate manufacture from development through piloting to production.

Responsibilities include writing batch/cleaning records, initiating SOPs and CAPAs, reviewing documentation, troubleshooting equipment, and coordinating with maintenance. The role requires 1–3 years in a pharma manufacturing environment and a BS in Chemical Engineering or equivalent.

Qualifications

BS in Chemical Engineering or similar field with 1–3 years manufacturing experience.
Experience in pharmaceutical manufacturing preferred.
Knowledge of cGMP, DEA/EPA compliance a plus.

Responsibilities

Write batch and cleaning records for commercial products or revisions.
Initiate SOPs and investigations, deviations, and CAPAs.
Review and approve documents for Operations as area expert.
Troubleshoot equipment and coordinate with maintenance.
Assist Process Engineers and Chemical Development teams when processes are transferred.
Develop and maintain IQ/OQ/PQ documentation and change controls.
Train Operators on equipment and process operations as needed.
Adhere to DEA, EPA, FDA and cGMP regulations.