Engineer

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.EngineerWhat you will doLet’s do this. Let’s change the world. In this vital role you will working in Combination Products Operation - Manufacturing Science and Technology, is responsible for engineering activities required for the development / qualification / validation and transfer of physical GMP test methods for combination products, devices, primary containers, and secondary packaging components.  The Engineer shall have the ability to work on multiple projects at one time that may involve changes or new product, processes, tooling or equipment introduction to improve quality and reliability and reduce cost.  Phases of projects include: developing combination product test methods, providing key expert support for qualification, validation, transfer, and life cycle support of methods for manufacturing, new product introduction, training, and production support.ResponsibilitiesDevelop, qualify, and validate GMP physical test methods for vials, prefilled syringes, and injection devices.Work in teams to transfer new combination product test method and assembly requirements to manufacturing, by developing six sigma processes and compiling documentation for manufacturing assembly requirements.Develop, qualify, validate, and transfer new equipment, software, systems, and methods.Implement projects per Combination Products Operation and company procedures to ensure projects are completed on schedule and within established budget.Provide expert support for investigations as well as new process development required to improve manufacturing operations. Coordinate test method development and delivery with selected contractors.Ensure that qualification parameters are met for product assembly requirements.Support development of cost estimates for new processes, gauges and equipment development used in generation of capital request documentation.Generate procedures necessary to support department and new process equipment.Provide expert training to individuals in the operation and maintenance of processes, test methods and equipment introduced to Quality Control and/or the manufacturing department (i.e. production operator, mechanics, process engineers).Participate in and assume responsibilities of team functions as assigned (i.e. Product Improvement Teams). Generate/author and own the Test Method documents.Gather test method requirements that result in equipment that operates safely and considers ergonomic factors in the designPerform other duties as required by the Group ManagerComply with the requirements, responsibilities, and authority as requiredMaintains integrated timelines capturing appropriate cross functional details and deliverables which are aligned with the functional and project goalsNetworks internally to ensure alignment, commitment to project objectives and timelines as well as to ensure effective execution of projectsNetworks with manufacturing, quality and regulatory organizations both internal and external to AmgenDrives the cross-functional communication and integration of information to optimize decision making, issue resolution and change management throughout project lifecycleExcellent verbal and written communication skills are utilized to communicate project status and risks associated with integrated timelines to leadershipCollaborates with other functional leaders to ensure project success, momentum and commitmentProactively identifies issues and/or risks and develops mitigation options to resolve or escalate efficientlyIntegrates partner/vendor timelines with Amgen timelines as appropriateWhat we expect of youWe are all different, yet we all use our unique contributions to serve patients. Engineer professional we seek is an individual with these qualifications.Basic Qualifications:Master’s degreeORBachelor’s degree and 2 years of engineering/scientific experienceORAssociate’s degree and 6 years of engineering/scientific experienceOR High school diploma / GED and 8 years of engineering/scientific experiencePreferred Qualifications:M.S. in Mechanical Engineering, Chemical or Biomedical Engineering, or ChemistryExcellent written and verbal communication skillsAbility to work in a highly matrixed team environment2 years of experience in the biotechnology/pharmaceutical industry2 years of experience in equipment, method, and mechanical designTechnical writing experienceExperience with SolidWorks (or other 3D-CAD software)Experience with combination products and regulatory requirementsExperience utilizing Minitab (or other statistical software packages)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.This role is paid hourly. Th