Senior Engineer I, Process Engineering
Core
Provide advanced technical expertise to support the design, implementation, and optimization of Drug Substance process technologies for mRNA and lipid nanoparticle (LNP) drug substance platforms across a global manufacturing network.
Role type
Senior Process Engineering Subject Matter Expert (SME)
Builds
Modular and small-scale process skids for commercial and clinical production
Domain
Biopharmaceutical manufacturing (mRNA, LNP)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Process design and scale-up, Equipment specification, Process simulation and modeling (mass/energy balances), GxP/GMP compliance, Root cause analysis, Technical documentation (PFDs, P&IDs, URS, FRS), Cross-functional collaboration
Preferred skills
Bioprocess skid design, Process analytical technologies (PAT), Personalized medicine manufacturing, FDA/EMA/ICH regulations knowledge, Mentorship
Technologies
IVT, Chromatography, Tangential Flow Filtration (TFF), Lipid Mixing (LMX), Lipid Nanoparticle (LNP) formulation
Responsibilities
Serve as technical SME for key Drug Substance processes, Support design and scale-up of process skids, Develop process flow diagrams and specifications, Contribute to Clean-In-Place system design, Collaborate on equipment design specifications, Support root cause investigations and continuous improvement, Mentor junior engineers
Seniority
Senior, hands-on IC with mentorship responsibilities
