Principal Process Engineer – API + OSD
Core
Lead front-end design programming and process engineering for Active Pharmaceutical Ingredients (API) and Oral Solid Dose (OSD) manufacturing, guiding clients from concept to commercial-scale implementation.
Role type
Principal Process Engineer (Pharmaceutical Manufacturing)
Builds
Pharmaceutical manufacturing facilities and process systems for API and OSD products
Domain
Life Sciences / Pharmaceutical Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
API process development, OSD process development, cGMP compliance, regulatory guidance interpretation, process characterization, technology evaluation, project scoping, equipment selection, P&ID development, Master Batch Record creation, contamination control, technical training
Preferred skills
Proposal generation, business development, industry conference presentation, white paper authoring, 3D modeling, process simulation
Technologies
AutoCAD, Microsoft Project, hydraulic analysis software, process simulation software
Responsibilities
Lead front-end design programming for API and OSD processes including site surveys and economic analysis; Define concepts and scale-appropriate solutions for pharmaceutical manufacturing; Manage regulatory impact reviews and FDA/EMA compliance; Develop process construction documents including P&IDs and equipment drawings; Interface with OEMs for equipment sizing and selection; Execute process system engineering from planning to detail design; Lead technical training and act as a subject matter expert for clients.
Seniority
Principal, hands-on IC with business development responsibilities