Manufacturing Engineer II - Front Line Engineering
Core
Direct floor-level technical owner and SME for Upstream manufacturing systems (Media Prep, Clean-in-Place, Bioreactors, PAT, Harvest) ensuring equipment fit-for-purpose, compliance, and uptime.
Role type
Manufacturing Engineer II (Front Line Engineering)
Builds
Upstream biopharmaceutical drug substance manufacturing systems and processes
Domain
Biopharmaceutical manufacturing / Upstream processing
Required skills
GMP compliance, root cause analysis (5 Whys, Ishikawa, Kepner-Tregoe, FMEA), equipment troubleshooting (mechanical/electrical/automation), equipment upgrades and modifications, capital project support, commissioning and qualification (IQ/OQ), data trending and analysis
Preferred skills
Biopharmaceutical unit operations experience, small to medium project management
Technologies
SAP, P&IDs, MS Office
Responsibilities
Triage and resolve routine equipment failures, lead formal root cause analysis investigations, monitor equipment performance metrics and identify trends, implement equipment upgrades and process improvements, support capital projects and technology transfers, provide 24/7 on-call technical support
Seniority
Mid-level, moderate supervision
