Process Engineer II (Upstream)
Core
Troubleshoot upstream manufacturing operations, perform root cause analysis, and execute process improvements for biopharmaceutical products.
Role type
Senior IC process engineer (upstream biomanufacturing)
Builds
Robust upstream manufacturing processes and product introductions
Domain
Biopharmaceuticals / Upstream cell culture
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Root cause analysis, process impact assessment, continuous process verification (CPV), technology transfer, change control management, master batch record review, risk assessment, study and validation protocol authoring
Preferred skills
Cell culture expertise, downstream process knowledge, cGMP compliance
Technologies
Upstream bioreactors, cell culture systems, CPV tools
Responsibilities
Lead troubleshooting of upstream process issues and perform root cause analysis; Analyze process trends and monitor performance within the CPV program; Plan and execute process improvements and robustness projects; Lead technology transfer activities for new products; Support audits, regulatory submissions, and responses; Adhere to EHS requirements.
Seniority
Mid-level, hands-on IC