MS&T Specialist
Core
Lead new product development and site transfer initiatives, including detailed process evaluation and plant infrastructure analysis.
Role type
Senior chemical process engineer (technology transfer)
Builds
New pharmaceutical products and manufacturing processes
Domain
Pharmaceutical manufacturing / Chemical engineering
Required skills
Process simulation, stoichiometry calculation, unit operations design, HAZOP studies, cGMP compliance, project scheduling, cross-functional coordination, utility requirement evaluation, troubleshooting unit operations, technology transfer management
Preferred skills
Dynochem proficiency, block and process flow diagram creation, investment requirement analysis, change control management
Technologies
Dynochem, Gantt charts
Responsibilities
Lead new product development and site transfer initiatives, Map processes to available plant capacity by selecting appropriate equipment, Conduct process simulations and prepare block and process flow diagrams, Coordinate cross-functional teams to deliver comprehensive evaluations, Develop and manage project schedules, Conduct safety assessments including HAZOP studies, Execute and document pre-validation and validation batches in compliance with cGMP guidelines, Prepare statutory documentation and change control reviews, Evaluate utility requirements and coordinate facility modification activities, Provide chemical engineering support to resolve unit operation challenges, Manage technology transfer activities, risk mitigation, and escalation protocols, Present project progress and findings to management
