Process Engineer II, Manufacturing Science & Technology (MSAT)
Core
Drives process optimization, technology transfer, and manufacturing scalability across 503A and 503B pharmaceutical operations using AI-enabled analytics and digital manufacturing systems.
Role type
Manufacturing Process Engineer II
Builds
Pharmaceutical manufacturing processes, packing operations, and commercial manufacturing readiness
Domain
Pharmaceutical manufacturing / Regulated manufacturing
Deliverable
production ML models | product features | dashboards & analysis | infrastructure
Required skills
Pharmaceutical manufacturing processes, process optimization, technology transfer, process validation, statistical process control, manufacturing science principles, packing operations, AI-enabled analytics platforms, manufacturing execution systems, statistical software, process monitoring technologies, digital manufacturing tools, cGMP requirements, risk-based decision-making
Preferred skills
Technology transfer, process validation, scale-up activities, manufacturing troubleshooting, continuous improvement initiatives, Lean Six Sigma Green Belt, Certified Pharmaceutical Industry Professional (CPIP), Professional Engineer (PE), Certified Quality Engineer (CQE)
Technologies
AI-enabled analytics platforms, manufacturing execution systems, statistical software, process monitoring technologies, digital manufacturing tools
Responsibilities
Develop and improve manufacturing processes for efficiency and compliance; Support technology transfer from development to commercial manufacturing; Execute process validation activities; Investigate manufacturing challenges and process deviations; Evaluate manufacturing data and process trends; Implement manufacturing solutions for efficiency and quality; Identify process risks and support mitigation planning; Drive continuous improvement initiatives
Seniority
Mid-level, hands-on IC
