Engineer I

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.Engineer I What you will doLet’s do this. Let’s change the world. In this vital role you will technically support manufacturing processes, secondary packaging operations, automated inspection systems, labeling technologies, and business applications while ensuring assigned systems remain qualified, compliant, and inspection ready throughout their lifecycle.The Engineer I serves as the System Owner for assigned assets and computerized systems, supporting engineering activities related to system reliability, lifecycle management, validation, change control, and operational excellence. The position collaborates closely with Quality, Manufacturing, Automation, Maintenance, Supply Chain, Information Systems, and Project teams to execute engineering activities in accordance with applicable regulatory requirements, corporate standards, and business objectives.System OwnershipServe as the System Owner for assigned manufacturing systems, computerized systems, packaging equipment, facility assets, utilities, and infrastructure.Maintain assigned systems in a qualified, compliant, reliable, and inspection-ready state throughout their lifecycle.Develop, maintain, and update engineering documentation including specifications, engineering assessments, lifecycle documentation, and technical reports.Review and support preventive maintenance strategies, calibration programs, engineering changes, and system improvements.Monitor system performance and implement reliability, operational excellence, and continuous improvement initiatives.Maintain computerized systems in compliance with applicable regulatory requirements, including vulnerability assessments and system lifecycle documentation.Support deployment and lifecycle activities for manufacturing technology projects, including operating system upgrades, endpoint management migrations, and infrastructure modernization initiatives.Provide technical ownership of SAP-integrated operational systems supporting shipping interfaces, label printing, scale connectivity, report tracking and automated packaging workflows.Manage business applications by supporting incident resolution, problem management, troubleshooting, and continuous system improvements.Manufacturing and Packaging SupportSupport manufacturing operations, secondary packaging processes, and shipping systems.Provide engineering support for labeling systems, barcode technologies, automated vision inspection systems, printers, scanners, and packaging automation.Troubleshoot technical issues affecting manufacturing and packaging operations while implementing sustainable engineering solutions.Support manufacturing process improvements that enhance equipment reliability, operational efficiency, and product quality.Quality and CompliancePerform technical investigations and root cause analyses using structured problem-solving methodologies.Support Change Control activities by performing engineering impact assessments, risk evaluations, and qualification assessments.Ensure engineering activities comply with GMP regulations, corporate engineering standards, and applicable regulatory requirements.Maintain documentation in accordance with Good Documentation Practices (GDP) and quality system expectations.Project SupportSupport capital projects, equipment upgrades, infrastructure improvements, and manufacturing system enhancements.Participate in project planning, design reviews, commissioning, Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), qualification, startup, and project turnover.Author, review, and execute validation documentation including Validation Plans, Risk Assessments, IQ/OQ/PQ protocols, engineering rationale documents, and validation summary reports.Review engineering designs and contractor deliverables to ensure compliance with regulatory, engineering, and business requirements.Coordinate validation and implementation activities with Engineering, Quality Assurance, Manufacturing, Automation, Supply Chain, and external contractors.Support project execution to achieve scope, schedule, budget, and quality objectives.Support implementation of SAP-integrated operational workflows and business process improvements.Audits and Inspection ReadinessSupport internal audits, customer audits, and regulatory inspections as the engineering subject matter expert for assigned systems.Present engineering documentation, validation packages, technical assessments, and qualification strategies during inspections.Support responses to audit observations and engineering-related quality actions.Maintain assigned systems and engineering documentation in a continuous state of inspection readiness.Cross-Functional CollaborationPartner with Quality, Manufacturing, Automation, Maintenance, Validation, Supply Chain, EHSS, and Information Systems to support site objectives.Collaborate with global engineering and technology teams during lifecycle projects and system deployments.Promote continuous improvement, operational excellence, and engineering best practices.Share technical knowledge and support the development of engineering solutions across functional teams.What we expect of youWe are all different, yet we all use our unique contributions to serve patients. The Engineer professional we seek is a dynamic with these qualifications.Basic Qualifications:Master’s degreeORBachelor’s degree and 2 years of Engineering experienceORAssociate’s degree and 4 years of Engineering experienceOR High school diploma / GED and 6 years of Engineering experiencePreferred Qualifications:Experience supporting GMP manufacturing or pharmaceutical operations.Knowledge of equipment lifecycle management and System Ownership principles.Understanding of GMP, data integrity, computerized system validation, and change control processes.Experience supporting manufacturing automation, packaging equipment, or industrial control systems.Experience participating in commissioning, qualification, and validation activities.Strong troubleshooting, analytical, and problem-solving skills.Excellent written and verbal communication skills with the ability to work effectively across cross-functional teams.Technical SkillsExperience or familiarity with:SAP ERPServiceNowMicrosoft Windows Operating Systems (Windows 10/11)Zebra printersDomino printersIndustrial barcode scannersLabel printing systemsAutomated vision inspection systemsPackaging automation equipmentManufacturing IT infrastructureComputerized System Validation (CSV)GMP documentation practicesCore CompetenciesTechnical problem solvingSystem ownership and accountabilityContinuous improvement mindsetCross-functional collaborationCustomer focusAttention to detailRegulatory complianceProject executionCommunication and technical documentationLearning agilityWhat 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 range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accountsA discretionary annual bonus program, or for field sales representatives, a sales-based incentive planStock-based long-term incentivesAward-winning time-off plansFlexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.Apply now and make a lasting impact with the Amgen team.careers.amgen.comIn any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.Application deadlineAmgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.SponsorshipSponsorship for this role is not guaranteed.As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation..Salary Range88,281.00USD -119,439.00 USDSummaryLocation: US - Kentucky - LouisvilleType: Full time