Lead process engineer
Core
Lead Process Engineer responsible for analyzing customer requirements, defining technical solutions, and executing complex downstream biopharmaceutical engineering projects.
Role type
Senior IC process engineer (downstream systems)
Builds
Custom engineered downstream systems for biopharmaceutical customers
Domain
Biopharmaceutical manufacturing / Downstream processing
Deliverable
product features
Required skills
downstream system design, process mass balance analysis, equipment selection and sizing, project management, technical proposal writing, project costing, FAT/SAT coordination, cross-functional coordination
Preferred skills
PLC/electrical design, system hardware validation, subcontractor management, GMP validation standards
Technologies
Chrom, IC, PUPSIT, Bulk filling, filtration, separation, purification, automation & electrical systems
Responsibilities
Analyze customer user requirements specifications, define technical solutions including process and instrumentation diagrams, develop project schedules and risk assessments, complete basic design and component lists, coordinate sub-supplier activities, monitor project progress and financial status, coordinate qualification/verification activities, create technical documentation, lead continuous improvement processes
Seniority
Senior, hands-on IC
