PAT Specialist
Core
Subject matter expert for Process Analytical Technology (PAT) driving technical excellence, innovation, and robust manufacturing performance in pharmaceutical production.
Role type
PAT Specialist (Pharmaceutical Manufacturing)
Builds
Digital process data, control strategies, and PAT measurement models for drug substance and drug product.
Domain
Pharmaceutical manufacturing / Process Analytical Technology
Deliverable
production ML models
Required skills
Chemometrics, NIR spectroscopy, Real-time release testing, Root-cause analysis, Multivariate data analysis, Technology transfer, Process validation, cGMP compliance, Equipment qualification
Preferred skills
Analytical Chemistry background, Chemical Engineering background, Pharmaceutical production technologies
Technologies
NIR spectroscopy, Multivariate data analysis tools
Responsibilities
Provide PAT support for inline production including NIR spectroscopy and real-time release; Deliver and implement PAT projects across cross-functional teams; Support investigations into PAT related issues performing root-cause analysis; Assist with technology transfer, process validation, and equipment qualification; Ensure compliance with PAT standards and SOPs; Contribute to training by delivering PAT learning sessions; Represent the site in global PAT forums; Drive continuous improvement by enhancing process robustness and supporting Quality Risk Management.
Seniority
Mid-Senior level, hands-on IC
