Process Analytical Technology (PAT) SME

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 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. Why Join Catalyx? At Catalyx we understand that our people are our greatest asset. For this reason and many others, we take care of them. The team in Catalyx benefits from a Total Rewards package. This includes great personal benefits and professional growth opportunities. Catalyx is an Equal Opportunity Employer. We are committed to creating a diverse and inclusive workplace where all individuals are valued, respected, and supported. We do not discriminate on the basis of race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age, disability, veteran status, genetic information, or any other characteristic protected by applicable law. We encourage applications from all qualified candidates, regardless of background, and strive to create a welcoming environment for everyone. At Catalyx, we are committed to attracting the best global talent. We proudly support our international employees by offering assistance with Critical Skills Visa applications for eligible candidates.