Process Engineer IV – MS&T
Core
Senior technical expert ensuring biologics manufacturing processes are capable, compliant, and continuously improved, focusing on single-use technology for drug substance operations.
Role type
Senior IC Process Engineer (Biologics Manufacturing)
Builds
GMP-compliant manufacturing processes and single-use assemblies for biologics drug substance
Domain
Biopharmaceutical manufacturing / Single-use technology
Required skills
Single-use assembly design and troubleshooting, GMP compliance, Process validation, Scale-up, Root cause investigation, Process data analytics, Regulatory documentation
Preferred skills
Biologics upstream/downstream unit operations, Perfusion/continuous operations, Extractable and leachable knowledge, Cross-functional team leadership, Process data analytics tools (DeltaV, LIMS, MES)
Technologies
DeltaV, Process Data Historian, LIMS, MES
Responsibilities
Lead design and troubleshooting of complex single-use assemblies (bioreactor bags, ATF devices, nano filtration), Provide technical leadership and guidance to manufacturing and quality teams, Apply advanced troubleshooting skills for manufacturing deviations, Review production data to assess process performance and identify improvements, Support documentation for regulatory purposes, Lead cross-functional project teams for process lifecycle improvements
Seniority
Senior, hands-on IC
