Engineer

Responsibilities

• Develop, 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 design
• Perform other duties as required by the Group Manager
• Comply with the requirements, responsibilities, and authority as required
• Maintains integrated timelines capturing appropriate cross functional details and deliverables which are aligned with the functional and project goals
• 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 cross-functional communication and integration of information to optimize decision making, issue resolution and change management throughout project lifecycle
• Excellent verbal and written communication skills are utilized to communicate project status and risks associated with integrated timelines to leadership
• Collaborates with other functional leaders to ensure project success, momentum and commitment
• Proactively identifies issues and/or risks and develops mitigation options to resolve or escalate efficiently
• Integrates partner/vendor timelines with Amgen timelines as appropriate
• What we expect of you
• We are all different, yet we all use our unique contributions to serve patients. Engineer professional we seek is an individual with these qualifications.

Requirements

• Master's degree
• OR
• Bachelor's degree and 2

Additional Information

Career Category Engineering Job Description Join Amgen's Mission of Serving Patients At 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

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