Senior Engineer System Owner Compliance

Job description

Career CategoryEngineeringJob DescriptionJoin Amgen’s Mission of Serving PatientsAt 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. SENIOR ENGINEER, SYSTEM OWNER COMPLIANCE What you will doLet’s do this. Let’s change the world. In this vital role you will partner across Facilities & Engineering, Manufacturing, Quality, Validation, Environmental Health & Safety, Supply Chain, Digital Technology & Innovation, and Capital Projects to ensure engineering activities support operational excellence while maintaining a constant state of inspection readiness. The successful candidate will demonstrate strong engineering judgment, ownership, technical leadership, and a continuous improvement mindset while driving compliance, reliability, and exceptional customer service. Provide system ownership for Biopharmaceutical compliance programs. Identify, support, and/or lead implementation of engineering-based improvements or upgrades to the facility systems. This may include development of business case for improvement and identification of design requirements and then translation of requirements into process equipment/system design, specification and supporting the construction, startup, and validation of equipment. Develop equipment maintenance programs, ensure the availability of spare parts, and coordinating maintenance execution as necessary to ensure systems are in proper working order. Ensure systems are installed and operating safety and comply with pertinent environmental health/safety practice, rules and regulations. Ensure necessary commissioning and qualification of systems is completed in alignment with GMP requirements and interact with regulatory inspectors as necessary. Monitor systems to identify performance risks and implement risk reduction strategies. Providing troubleshooting support to reduce production downtime. This will involve leading and/or supporting technical root cause analysis and implementation of corrective/preventive action. Support new product/technology introductions by performing engineering assessments, implementing equipment modifications, and supporting engineering runs. Facilities Quality & Compliance Serve as the technical lead for Facilities Quality & Compliance programs supporting GMP manufacturing operations. Ensure facility systems, utilities, maintenance programs, engineering activities, and documentation remain compliant with cGMP regulations, Amgen standards, and engineering requirements. Maintain Facilities & Engineering in a continuous state of inspection readiness through proactive compliance monitoring and risk mitigation. Partner with Quality Assurance during internal audits, corporate audits, customer audits, and regulatory inspections. Quality Systems Ownership Own facility-related Deviations from initiation through closure, including investigation leadership, root cause analysis, effectiveness verification, and timely implementation of corrective actions. Lead structured investigations using risk-based methodologies including 5-Why, Fishbone, Kepner-Tregoe, and Human Performance principles. Own engineering Change Controls, ensuring appropriate impact assessments, stakeholder alignment, and compliant implementation. Own & Manage Deviations from initiation through timely closure, ensuring sustainable corrective and preventive actions. Manage CAPAs from initiation through effectiveness verification, ensuring sustainable corrective and preventive actions. Monitor quality metrics, identify emerging compliance trends, and proactively mitigate risks. Engineering & Maintenance Excellence Support commissioning, qualification, startup, and lifecycle management of facility systems and utilities. Develop and approve engineering procedures, maintenance strategies, technical reports, and risk assessments, as needed. Ensure engineering documentation complies with Good Documentation Practices (GDP). Continuous Improvement Champion a continuous improvement mindset by simplifying processes, reducing compliance risk, improving equipment reliability, and enhancing operational performance. Lead improvement initiatives utilizing Lean, Six Sigma, Operational Excellence, and data-driven decision making. Business Partnership Build trusted partnerships across Manufacturing, Quality, Validation, EHS, Supply Chain, and Engineering. Demonstrate a proactive, customer service mindset by delivering responsive engineering solutions while balancing compliance, reliability, and business needs. Influence cross-functional teams without direct authority while fostering ownership, accountability, and collaboration. What we expect of youWe are all different, yet we all use our unique contributions to serve patients. The Professional we seek is a person with these qualifications. Basic Qualifications: High school diploma / GED and 10 years Engineering experience OR Associate’s degree and 8 years of Engineering experience OR Bachelor’s degree and 4 years of Engineering experience OR Master’s degree and 2 years of Engineering experience OR Doctorate degree Preferred Qualifications: Bachelor’s degree in Chemical or Mechanical Engineering 6+ years' of relevant work experience with 5+ years' experience in Biopharmaceutical operations/manufacturing environment Ability to analyze problems, develop and propose engineering solutions in a scientific manner using data-driven techniques and analyses (e.g., Data Analytics, Root Cause Analysis (RCA), Statistical Process Control (SPC), Six Sigma, Predictive Maintenance, etc.) Experience working in a regulated environment (e.g. cGMP, OSHA, EPA, etc.) and familiarity with GMP quality systems/processes such as change control, non-conformances, corrective and preventative actions, and qualifications/validation Experience applying engineering principles to the design and implementation of system modifications, introduction of new processes, and execution of capital projects Understanding of the execution process of capital projects in a GMP Biopharmaceutical Production facility including procurement, construction, startup, and validation Understanding of safety requirements working in a GMP Biopharmaceutical Production facility. Independent, ambitious, organized, able to multi-task in project environments, and skilled in communication, facilitation, and teamwork Great teammate prepared to work in and embrace a team based culture that relies on collaboration for effective decision-making Strong leadership, technical writing, and communication/presentation skills Work schedule flexibility as required to support 24/7 operations, requiring occasional after-hours engineering coverage Ability for domestic/international travel What you can expect of usAs we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. The expected annual salary