Sr. Validation Scientist AML14 - Aseptic Validation

Job description

Career CategoryProcess DevelopmentJob DescriptionJoin Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Sr. Validation Scientist AML14 - Aseptic Validation What you will do Let’s do this. Let’s change the world! In this vital role, you will provide expert technical leadership and hands-on validation support for aseptic drug product manufacturing operations across AML. You will lead and support aseptic process simulations, airflow visualization studies, Environmental Monitoring Performance Qualifications, validation strategies, investigations, process changes, new product introductions, and facility or equipment modifications. As a Subject Matter Expert in Aseptic Validation, you will collaborate across Manufacturing, Engineering, Process Development, Facilities, Utilities, Microbiology, Environmental Monitoring, Quality Control, and Quality Assurance to ensure validation activities are scientifically sound, risk-based, compliant, and completed on schedule. You will also troubleshoot complex validation issues, support the continued qualified state, contribute to the Contamination Control Strategy and validation standards, and represent the organization during technical reviews, audits, and regulatory inspections. Specific Responsibilities Responsibilities include, but are not limited to: Provides independent technical guidance and hands-on aseptic process validation support for parenteral drug product manufacturing operations. Supports the qualification, continued control, and improvement of aseptic processes, equipment, facilities, utilities, laboratories, and supporting systems. Develops and implements validation strategies for new product introductions, process and equipment changes, facility modifications, capital projects, and other complex technical assignments. Applies advanced validation principles, scientific judgment, and risk-based approaches to address complex aseptic processing and validation challenges. Authors, reviews, and approves validation master plans, protocols, reports, risk assessments, periodic reviews, and other supporting technical documentation. Ensures validation activities and documentation comply with cGMP requirements, approved procedures, regulatory expectations, and applicable industry standards. Develops, plans, coordinates, executes, and evaluates aseptic process simulations, including media fills designed to represent routine operations, interventions, and worst-case manufacturing conditions. Plans, coordinates, executes, and evaluates airflow visualization studies in Grade 5 and other critical aseptic processing areas, including assessment of first-air protection, personnel practices, interventions, equipment configurations, and contamination risks. Supports the development, execution, and maintenance of science- and risk-based Environmental Monitoring Performance Qualification strategies for new, modified, and existing classified manufacturing areas. Reviews and interprets media fill, airflow visualization, EMPQ, environmental monitoring, cleanroom qualification, and related validation data to assess aseptic process performance and the state of contamination control. Assesses the effect of process, equipment, facility, HVAC, cleaning and disinfection, personnel practices, material flows, maintenance activities, and operational changes on the validated or qualified state. Determines validation, requalification, additional monitoring, remediation, or repeat-study requirements based on changes, deviations, adverse trends, or unexpected results. Troubleshoots systemic aseptic processing and validation issues and leads or supports investigations, root-cause analyses, impact assessments, CAPAs, and remediation activities. Provides aseptic validation assessments and technical input for change controls, deviations, nonconformances, CAPAs, audit observations, and other Quality Management System records. Collaborates with Manufacturing, Process Development, Engineering, Facilities, Utilities, Laboratories, Environmental Monitoring, Microbiology, Quality Control, Quality Assurance, and other applicable functions. Works with project managers and multidisciplinary teams to complete validation deliverables for engineering projects, facility modifications, capital projects, and new product introductions within schedule, budget, quality, and compliance requirements. Develops or contributes to validation policies, procedures, standards, and technical practices that may affect multiple departments or organizational units. Provides technical direction, training, coordination, and review of work performed by validation scientists, contractors, consultants, vendors, and project team members, as assigned. Supports the development, implementation, maintenance, and periodic review of the site Contamination Control Strategy from an aseptic process validation perspective. Participates in technical and governance forums, including the Environmental Control Network, Aseptic Council, Contamination Control Network, and other committees, as assigned. Supports continuous improvement initiatives related to aseptic processing, validation, environmental control, and contamination prevention. Identifies and escalates significant quality, compliance, supply, operational, and safety risks to appropriate management. Presents validation strategies, study results, conclusions, risks, and recommendations to technical teams, governance forums, senior management, auditors, and regulatory inspectors. Supports internal and external audits, regulatory inspections, and responses to audit or inspection observations. Maintains timely and regular attendance and complies with applicable site safety, quality, and operational requirements. What we expect of you We are all different! Yet, we all use our unique contributions to serve patients. The Sr. Validation Scientist professional we seek is a Quality-driven professional with these qualifications: Basic Qualifications Doctorate degree OR Master’s degree & 3 years of Validations and Quality experience OR Bachelor’s degree & 5 years of Validations and Quality experience OR Associate’s degree and 10 years of Validations and Quality experience OR High school diploma / GED and 12 years of Validations and Quality experience Preferred Qualifications Bachelor’s degree in Engineering, or a related technical discipline. Advanced knowledge of aseptic processing, including microbiological principles, aseptic techniques, gowning practices, cleanroom classifications, sterile-system boundaries, and the assembly and operation of aseptic manufacturing lines. Demonstrated experience with aseptic process simulations, including media fill strategy, execution, interventions, data assessment, and applicable regulatory and industry expectations. Demonstrated experience planning, executing, or evaluating airflow visualization studies and Environmental Monitoring Per