Process Engineer II - Cambrex

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. 

• 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 

• 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 

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