Senior Process Engineer (New Product Introduction)
Core
Lead end-to-end technology transfer and process scale-up for new API products from R&D to commercial manufacturing in a GMP-regulated environment.
Role type
Senior Process Engineer (New Product Introduction)
Builds
New API pharmaceutical products for global commercialization
Domain
Pharmaceutical manufacturing / Chemical processing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Technology transfer, process troubleshooting, deviation investigation (RCA/CAPA), GMP compliance, process validation, project management, scale-up, automation system optimization
Preferred skills
API manufacturing in Singapore, Emerson deltaV systems, FMEA, lifecycle management, global tech transfer
Technologies
deltaV, Emerson
Responsibilities
Lead technology transfer activities and define equipment modifications for scale-up; Perform process troubleshooting and lead deviation investigations; Develop manufacturing instructions and SOPs in compliance with GMP; Drive process readiness and validation activities; Implement process improvements to enhance yield and robustness; Manage NPI project timelines and resources
Seniority
Senior, hands-on IC