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Engineer - Container Closure Integrity_

3 months ago

Thousand Oaks, United States Amgen Full time

**HOW MIGHT YOU** **DEFY** **IMAGINATION** **?** You’ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role. **Engineer -** **Container** **Closure** **Integrity** **Live** **What you will do** Let’s do this. Let’s change the world. In this vital role The Engineer, in Container Closure Integrity, 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 parts related to container closure integrity. 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 experienced support for qualification, validation, transfer, and life cycle support of methods for manufacturing, new product introduction, training, and production support. Responsibilities: + Develop, qualify, and validate GMP physical testmethodsfor vials, prefilled syringes, and injection devices relatedtocontainerclosureintegrity. + Manage implementation of equipment and technology relatedtocontainerclosureintegrity and associated processes + Work in teams to transfer new combinationproducttest method and assembly requirements to manufacturing, by developing six sigma processes and compiling documentation for manufacturing assembly requirements. + Implement projects per Manufacturing Science and Technology organization and company procedures to ensure projects are completed on schedule and within established budget. + Provide experiencedsupportfor investigations as well as new process development required to improve manufacturing operations. + 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 experienced 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). + Generate/author and beresponsiblefor the Test Method documents. + Gather test method requirements that result in equipment that operates safely and considers ergonomic factors in the design + Performotherduties as required by the Group Manager + Maintains integrated timelines collecting appropriate multi-functional details and work which are aligned with the functional and project work + Networks internally to ensure alignment, commitment to project objectives and timelines as well as to ensure effective execution of projects + Networks with manufacturing, quality and regulatory organizations both internal and external to Amgen + Drives the multi-functional communication and integration of information to optimize decision making, issue resolution and changemanagement throughout project lifecycle + Excellent verbal and written communication skills are applied to communicate project status and risks associated with integrated timelines to leadership + Integrates partner/vendor timelines with Amgen timelines as appropriate The position will require approximately 10% travel to international locations assisting our development partners during implementation of container closure integrity methods into their processes. **Win** **What we expect of you** We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a go getter with these qualifications. **Basic Qualifications:** Master’s degree Or Bachelor’s degree and 2 years of engineering/scientific experience. Or Associate’s degree and 6 years of engineering/scientific experience. Or High school diploma / GED and 8 years of engineering/scientific experience. **Preferred Qualifications:** + M.S. in Mechanical Engineer, Chemical or Biomedical Engineering, or Chemistry + Excellent written and verbalcommunicationskills + Abilitytowork in a highly matrixed teamenvironment + 2yearsofexperiencein the biotechnology/pharmaceutical industry + 2yearsofexperiencein equipment, method, and mechanical design + Technical writing experience + Experience with SolidWorks (or other 3D-CAD software) + Experience with combination products and regulatory requirements + Experience applying Minitab (or other statistical software packages) + Experience with containerclosureintegrity testing **Thrive** **What you can expect of us** As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being. 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. Amgen offers a Total Rewards Plan comprising 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 including: + Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical,dentalandvisioncoverage,lifeanddisabilityinsurance, and flexiblespendingaccounts. + A discretionaryannualbonusprogram, or for field sales representatives, a sales-based incentive plan + Stock-based long-term incentives + Award-winning time-off plans and bi-annual company-wide shutdowns + Flexible work models, including remote work arrangements, where possible **Apply now** **for a career that** **defies** **imagination** Objects in your future are closer than they appear. Join us. **careers.amgen.com** Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. 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.