Process Engineer II

2 months ago

Charles City, United States Cambrex Full time

Overview:

The Process Engineer II 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 with minimal oversight to support production operations
  • Identifying and monitoring KPIs and using process data to identify and execute improvements to new and existing products to achieve improved yields, quality or customer expectations
  • Identifying and executing Kaizen events with support from Process Improvement
  • 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 with minimal oversight
  • Leading efforts to troubleshoot and investigate process problems and deviations with minimal guidance, 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
Qualifications / Skills::
  • Knowledge of and/or direct experience in a cGMP environment is preferred
  • General knowledge of chemical operations equipment and manufacturing operations
  • Proficient in windows based environment including word processing, spreadsheet and data base programs


Qualifications:

BS in Chemical Engineering, plus 3 7 years or more of experience in manufacturing environment, preferably in pharmaceutical manufacture; or equivalent education/experience

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