Process Engineer
Current• 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.•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, R&D, •Regulatory, Quality Control, Analytical Development and Operations•Developing plans for production of pilot and commercial volumes of product•Developing and maintaining IQ, OQ, 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 CAPA's and audit action items as assigned
