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Engineer - Container Closure Integrity

3 months ago

Thousand Oaks, United States Amgen Full time
HOW MIGHT YOU DEFY IMAGINATION?Youve 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 missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds 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 LiveWhat you will doLets do this. Lets 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 test methods for vials, prefilled syringes, and injection devices related to container closure integrity.Manage implementation of equipment and technology related to container closure integrity and associated processesWork 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.Implement projects per Manufacturing Science and Technology organization and company procedures to ensure projects are completed on schedule and within established budget.Provide experienced support for 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 be responsible for 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 ManagerMaintains integrated timelines collecting appropriate multi-functional details and work which are aligned with the functional and project workNetworks 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 multi-functional communication and integration of information to optimize decision making, issue resolution and change management throughout project lifecycleExcellent verbal and written communication skills are applied to communicate project status and risks associated with integrated timelines to leadershipIntegrates partner/vendor timelines with Amgen timelines as appropriateThe position will require approximately 10% travel to international locations assisting our development partners during implementation of container closure integrity methods into their processes.WinWhat we expect of youWe 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:Masters degree OrBachelors degree and 2 years of engineering/scientific experience. OrAssociates degree and 6 years of engineering/scientific experience. OrHigh school diploma / GED and 8 years of engineering/scientific experience. Preferred Qualifications:M.S. in Mechanical Engineer, 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 applying Minitab (or other statistical software packages)Experience with container closure integrity testingThriveWhat you can expect of usAs 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, dental and vision coverage, life and disability insurance, and flexible spending accounts. A discretionary annual bonus program, or for field sales representatives, a sales-based incentive planStock-based long-term incentives Award-winning time-off plans and bi-annual company-wide shutdowns Flexible work models, including remote work arrangements, where possibleApply nowfor a career that defies imaginationObjects in your future are closer than they appear. Join us.careers.amgen.comAmgen 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.