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Process Engineer I

3 months ago

Charles City, United States Cambrex Full time

Overview:

The Process Engineer I will be responsible for implementation of projects for the manufacture of APIs and bulk intermediates and other products from development through piloting and/or commercial production.

Responsibilities:
  • Writing batch records, cleaning records, SOPs, campaign reports, supplements, and investigation/deviation reports as needed to support production operations
  • Monitoring KPIs and using process data to identify and execute improvements to new and existing products to achieve improved yields, quality or customer expectations
  • Working with process improvement to identify and execute Kaizen events
  • Providing training and process support to production areas including training on new processes and on-site oversight of key processing steps
  • Working in a team environment that includes cross-departmental participation from Engineering, Research and Development, Regulatory, Quality Control, Analytical Development and Operations
  • Developing plans for production of pilot and commercial volumes of product
  • Developing and maintaining IQ, OQ and PQ documents and protocols
  • Troubleshooting, investigating process problems and deviations, and preparing appropriate reports on findings
  • Participating in HAZOPs and providing guidance on corrective actions when needed
  • Providing PFD and P&ID generation, energy balances, material balances, environmental calculations and other calculations and formulations as needed
  • Working with appropriate departments to set up codes, label requests, and MSDS revisions
  • Completing CAPAs and audit action items as assigned

All employees are required to adhere to DEA, EPA, FDA and cGMP regulations as they relate to the operation of the Company; and to adhere to all company safety rules and procedures. All employees are expected to report to work regularly and promptly. Other duties relating to departmental mission, not specifically detailed in this section may be assigned.

Qualifications / Skills::
  • Knowledge of and/or direct experience in a cGMP environment is preferred
  • General knowledge of chemical operations equipment and manufacturing operations


Qualifications:

BS in Chemical Engineering, plus 1 3 years of experience in manufacturing environment, preferably in pharmaceutical manufacture; or equivalent education/experience