Engineer - Physical Methods

Amgen • Cambridge, MA

1d

About The Position

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. 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 – Physical Methods What you will do Let’s do this. Let’s change the world. The Engineer, in Physical Methods, 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. 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.

Requirements

• High school diploma / GED and 8 years of Engineering / Scientific experience OR
• Associate’s degree and 6 years of Engineering / Scientific experience OR
• Bachelor’s degree and 2 years of Engineering / Scientific experience OR
• Master’s degree

Nice To Haves

• M.S. in Mechanical Engineer, Chemical or Biomedical Engineering, or Chemistry
• Excellent written and verbal communication skills
• Ability to work in a highly matrixed team environment
• 2 years of experience in the biotechnology/pharmaceutical industry
• 2 years of experience in 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)

Responsibilities

• Method Lifecycle: Develop, qualify, validate, and transfer 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 operational processes.
• Coordinate test method development and delivery with selected contractors.
• 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.
• Equipment Lifecycle: Generate procedures necessary to support department and new process equipment.
• Develop, integrate, and implement new process technology and equipment.
• Assess, manage, and implement equipment lifecycle changes.
• General: Implement projects per Final Product Technologies 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.
• Participate in and assume responsibilities of team functions as assigned (i.e. Product Improvement Teams).
• 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
• Align with the requirements, responsibilities, and authority as required
• Maintains integrated timelines collecting appropriate multi-functional details and work which are aligned with the functional and project work
• Network 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
• Drive multi-functional communication and integrate information to optimize decision making, issue resolution and change management throughout project lifecycle
• Demonstrate excellent verbal and written communication skills are applied to communicate project status and risks associated with integrated timelines to leadership
• Collaborate with other functional leaders to ensure project success, momentum and commitment
• Proactively identify issues and/or risks and implement solutions that resolve issues or increase efficiency.
• Integrate partner/vendor timelines with Amgen timelines as appropriate

Benefits

• 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 accounts
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans
• Flexible work models where possible.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level