Process Analytical Technology (PAT) SME

Job description

Catalyx is seeking a Process Analytical Technology (PAT) Subject Matter Expert supporting the implementation, expansion, and lifecycle management of PAT systems within a biopharmaceutical manufacturing environment. Specialized in configuring and maintaining Siemens SIPAT to enable real-time process monitoring, data integrity, and regulatory compliance. Key Responsibilities: ·: Supported the expansion,: optimization, and ongoing maintenance of a large-scale PAT framework within a GMP-regulated biopharmaceutical manufacturing site. ·: Installed, configured, and: maintained Siemens SIPAT infrastructure, including central databases, base stations, and collector stations. ·: Developed, configured, and: executed SIPAT methods, multivariate models, and automated interventions for real-time process control. ·: Designed and generated: analytical and compliance reports using SAP Business Objects to support process monitoring and decision-making. ·: Collaborated with: cross-functional teams to plan and execute major system upgrades between SIPAT versions, ensuring minimal disruption to manufacturing operations. ·: Authored and executed: validation documentation, including Installation Q...