Development Engineer (Snr Specialist)
Core
Lead the design, scale-up, and transfer of new solid oral dosage (OSD) manufacturing processes to support commercialization and production.
Role type
Senior Specialist Development Engineer (Pharmaceutical Process Development)
Builds
Robust, validated commercial manufacturing processes for solid oral dosage forms
Domain
Pharmaceutical manufacturing / Solid oral dosage (OSD) technology
Required skills
Process chemistry, formulation technology, scale-up, technology transfer, cleaning validation, cGMP compliance, Quality Risk Management (QRM), root-cause analysis, project management, Lean Six Sigma
Preferred skills
Advanced degree (MSc, PhD), experience with deviation management systems, production operations
Technologies
None explicitly listed beyond general engineering tools
Responsibilities
Lead design, scale-up, and transfer of new OSD manufacturing processes; Lead cross-functional teams for Quality Risk Assessments and investigations; Author and execute process and cleaning validation programs; Provide high-level technical troubleshooting for manufacturing processes; Operate as a project leader for new product introductions; Implement process improvements using Lean Six Sigma tools
Seniority
Senior, hands-on IC with leadership responsibilities