Job Description
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 Qualification (IQ) and Operational Qualification (OQ), ensuring compliance with regulatory standards (e.g., FDA, GMP). · Provided technical support and troubleshooting for PAT systems, ensuring data integrity and system reliability. · Contributed to continuous improvement initiatives by enhancing PAT capabilities and aligning with evolving manufacturing and regulatory requirements. Requirements · Bachelor’s degree in Engineering, Pharmaceutical Sciences, Chemistry, or a related scientific/technical field (Master’s preferred). · 3–7+ years of experience in biopharmaceutical or pharmaceutical manufacturing environments. · Hands-on experience with Siemens SIPAT or similar Process Analytical Technology (PAT) platforms. · Strong understanding of PAT principles, multivariate data analysis, and real-time process monitoring. · Experience with system configuration, including databases, instrumentation interfaces, and data acquisition systems. · Familiarity with reporting tools such as SAP Business Objects or equivalent platforms. · Demonstrated experience with Computer System Validation (CSV), including IQ/OQ (PQ is a plus). · Solid knowledge of GMP regulations and FDA guidelines related to pharmaceutical manufacturing systems. · Experience supporting or executing system upgrades and lifecycle management in regulated environments. · Strong problem-solving skills with the ability to troubleshoot complex technical systems. · Excellent communication and collaboration skills, with experience working in cross-functional teams.