The Monday to Friday Process Engineer role for Commercial manufacturing operations is responsible for operational representation and execution with primary focus on the execution of manufacturing processes, technical assessment for processes (investigation support and impact assessment), maintaining a culture of compliance, innovation, and continuous improvement within the assigned Asset Group.
The process engineer will lead troubleshooting activities, Process Robustness , provide investigations support, analyze process data, and identify and implement process improvements and be part of a culture of continuous improvement.
Represent operations on cross functional projects to improve performance of the site.
Drive continuous improvement in the work processes associated with support of commercial manufacturing and change management.
As applicable work on Efficiency projects for Poly process, increased cadence, process robustness
Work with network counterparts such as Grange Castle and Sanford in support of any downstream impact or process related issues.
The person will have regular interactions with the Engineering, Quality, Site Technical Services, and Operational Management departments.
Execute , review and approval of change controls, protocols, procedures, and MBRs
Oversight and management of training requirements
Responsible for participation and execution within Process monitoring - real-time and trend analysis
Process robustness support for IMEX (Integrated Manufacturing Excellence)
Support of audits (internal and external) including walkthroughs, response, and driving closure of any observations
Provide support during audits and with audit observation closure
BA/BS in chemical engineering, biology, biochemistry or related science or engineering field
Minimum of 4 years relevant experience with Bachelors engineering degree or an MS with +2 yrs
Minimum of 6 years relevant experience with Bachelors science degree or an MS with +4 yrs
Familiarity and experience with one of the following unit operations: mammalian cell culture or microbial fermentation , centrifugation, tangential flow filtration, column chromatography.
Hands on experience with the above unit operations at manufacturing scale
Previous experience in a GMP manufacturing environment
Previous experience with process validation, change management, tech transfer, or project management
Previous experience with scale up of the unit operations
Experience with Six Sigma, Method 1, 5S and/or other operational excellence programs
Work will include walking throughout the manufacturing suite including up and down stairs.
An ability to cross reference multiple documents and perform a detailed review of documentation is required.
The role requires work in a GMP manufacturing suite which requires gowning.
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