Process Engineer
Core
Lead technology transfer and process engineering for a new sterile powder filling facility, ensuring compliance with EU-GMP and FDA regulations for global animal health supply.
Role type
Process Engineer (Pharmaceutical Manufacturing)
Builds
New end-to-end facility for sterile suspended pharmaceuticals and small molecule products
Domain
Pharmaceutical manufacturing / Animal health / Sterile processing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Technology transfer, GMP compliance, Root cause analysis, Project management, Process optimization, Cross-functional collaboration, Regulatory inspection support, Lean Six Sigma, Statistics, Powder handling
Preferred skills
Column chromatography, Equipment setup, Environmental Health and Safety (EHS) management, Visual management, Training and development
Technologies
Powder filling lines, Sterile manufacturing equipment, GMP validation systems
Responsibilities
Manage end-to-end technical projects for API, packaging, and process changes; Lead root cause investigations of major manufacturing or quality issues; Introduce new technology platforms; Provide in-line product support and implement productivity initiatives; Support regulatory inspections for GMP systems; Engage in knowledge management and best practices sharing
Seniority
Mid-level, hands-on IC
