Sr Project Engineer
Core
Directing project teams to design, develop, and implement manufacturing technologies for complex pharmaceutical formulations, specifically parenteral nutrition and generic drugs.
Role type
Senior Project Engineer (Pharmaceutical Process Engineering)
Builds
Production-scale manufacturing processes and equipment for lipid emulsions, lyophilized products, and total parenteral nutrition (TPN).
Domain
Pharmaceutical manufacturing / Process Engineering
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Emulsion formulation design, Lyophilization process design and scale-up, High-pressure homogenization, Microfluidization, Steam sterilization, UHT sterilization, Process flow diagram calculation, P&ID design, 3D modeling, Equipment specification, Risk assessment, Vendor coordination, GMP compliance, Batch/continuous process system design, Lab to production scale-up support, Troubleshooting aseptic formulation.
Preferred skills
Advanced degree in chemical/process/pharmaceutical engineering, Project management in regulated environments, Clean room classification knowledge, Critical utilities experience (WFI, OFCA, Clean Steam, HVAC), CIP/SIP experience, Cytotoxic/Potent API handling, Six Sigma training, AutoCAD or SolidWorks proficiency.
Technologies
High-pressure homogenizers, Microfluidizers, Freeze-driers, AutoCAD, SolidWorks
Responsibilities
Lead project teams in technology transfer from lab to manufacturing scale; Design conceptual designs and P&IDs for GMP-based manufacturing; Analyze production problems and initiate project definitions to resolve them; Develop process specifications for formulation equipment and product delivery systems; Coordinate vendor activities and ensure compliance with safety and regulatory codes; Prepare URS, Risk Assessments, and Safety Assessments; Maintain Process Instructions in accordance with Change Control and Validation requirements.
Seniority
Senior, hands-on IC
