Description

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. 

• 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 

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

PI277795082