Process Engineer III
Core
Develop, validate, and transfer biopharmaceutical manufacturing processes for biologics medicines.
Role type
Senior IC process engineer (biologics manufacturing)
Builds
Manufacturing processes for biologics medicines
Domain
Biopharmaceuticals / Biologics
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP compliance, process validation, unit operations (cell culture, harvest, purification), SOP development, batch record management, deviation analysis, equipment design changes, project management, technical troubleshooting, training
Preferred skills
Statistical methods for process analysis
Technologies
Microsoft Word, Excel
Responsibilities
Draft and approve SOPs, job aids, batch records, and validation protocols; Collaborate on standardized methodologies for unit operations; Lead client projects and manage timelines; Identify error-proofing opportunities and drive engineering initiatives; Assess impact of GMP deviations on product quality; Lead changes to equipment and process design; Troubleshoot technical challenges on the manufacturing floor; Provide training for Process Engineers/Scientists
Seniority
Senior, hands-on IC
