Immanuel Moss

Background

About Immanuel Moss

As a Quality Assurance Validation Manager at Kiniksa Pharmaceuticals, a biopharmaceutical company that focuses on finding, acquiring, developing, and commercializing therapeutic medicines for patients with significant unmet medical needs, I am responsible for ensuring that the lab and process equipment used in developing and manufacturing life-saving drugs are designed, qualified, and maintained in control, following regulatory and industry standards. With almost a decade of validation engineering experience, my core competencies include computer system validation (CSV), cleaning in place/sterilization in place (CIP/SIP), data integrity, risk assessment, and continuous improvement. I am passionate about learning new technologies and staying updated with the latest trends and best practices. By pursuing a master's degree in computer science, I can apply my programming and analytical skills to enhance the quality and efficiency of the validation processes. I lead and collaborate with cross-functional teams to author, review, and execute validation protocols, test scripts, and reports and support change control, CAPA, and deviation management. I also oversee the CSV activities for GxP systems and perform risk-based assessments and gap analysis to ensure data integrity and compliance. My goal is to deliver high-quality results and contribute to the success and growth of the company.