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Process Engineer II

2 months ago

Charles City, Iowa, United States Cambrex High Point Full time
About the Role

Cambrex High Point is seeking a highly skilled Process Engineer II to join our team in the manufacture of APIs and bulk intermediates. As a key member of our production team, you will be responsible for implementing projects from development through piloting and commercial production.

Key Responsibilities
  • Develop and implement batch records, cleaning records, SOPs, campaign reports, supplements, and investigation/deviation reports to support production operations.
  • Identify and monitor KPIs, using process data to identify and execute improvements to new and existing products to achieve improved yields, quality, or customer expectations.
  • Develop and execute Kaizen events with support from Process Improvement.
  • Provide training and process support to production areas, including training on new processes and on-site oversight of key processing steps.
  • Work in a team environment that includes cross-departmental participation from Engineering, Research and Development, Regulatory, Quality Control, Analytical Development, and Operations.
  • Develop plans for production of pilot and commercial volumes of product.
  • Develop and maintain IQ, OQ, and PQ documents and protocols.
  • Lead efforts to troubleshoot and investigate process problems and deviations, and prepare appropriate reports on findings.
  • Participate in HAZOPs and provide guidance on corrective actions when needed.
  • Provide PFD and P&ID generation, energy balances, material balances, environmental calculations, and other calculations and formulations as needed.
  • Work with appropriate departments to set up codes, label requests, and MSDS revisions.
  • Complete CAPAs and audit action items as assigned.
Requirements
  • 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 database programs.
Qualifications
  • BS in Chemical Engineering, plus 3-7 years or more of experience in a manufacturing environment, preferably in pharmaceutical manufacture; or equivalent education/experience.