Process Engineer III - Floor Support
Core
Provide technological input in the development, validation, and transfer of manufacturing processes for biologics/pharma, acting as a subject matter expert on customer programs.
Role type
Senior IC Process Engineer (Biopharmaceutical Manufacturing)
Builds
Manufacturing processes, validation protocols, batch records, and equipment/process designs for biologics production.
Domain
Biopharmaceuticals / GMP Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP compliance, process validation, deviation management, batch record drafting, equipment design, project management, technical troubleshooting, data analysis, SOP review, training delivery
Preferred skills
Statistical methods for pharmaceutical process analysis, MSAT team collaboration
Technologies
Microsoft Word, Excel
Responsibilities
Troubleshoot technical challenges on the manufacturing floor; manage internal and client projects with minimal supervision; assess and approve impact of major GMP deviations; lead changes to equipment and process design; draft and approve Manufacturing Batch Records and validation protocols; analyze and trend process data; provide technical feedback on cross-departmental documents; support MSAT team tasks; provide development and training for Process Engineers/Scientists.
Seniority
Senior, hands-on IC