Senior Engineer, Combination Products - Process Engineering

Career Category

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. 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.

Senior Engineer

What you will do

Let’s do this. Let’s change the world. In this vital role you will lead part of development, and lifecycle management of manufacturing processes for drug delivery drug/device combination products. This includes technical operations support for design control activities, device manufacturing, failure investigations, leading and assessing design changes impact to manufacturing, developing test procedures, leading scale-up and global launch, and continuous improvement. Responsibilities of this position may include:

• Lead process characterization of prefilled syringe delivery systems, including packaging, labeling, and accessories.
• Lead process improvements, conduct analytical failure analysis, and implement process solutions.
• Author technical records and ensure they are appropriately maintained in the e.g. Device Master record (DMR)/Master Manufacturing Record (MMR)
• Author technical content in Tech Transfer.
• Represent Process engineering within a large network/matrix organization.
• Evaluate test methods, prototype designs, and optimize products and processes using DOE and statistical techniques.
• Monitor project progress, identify risks, and implement mitigation strategies to ensure project landmarks and timelines are met.
• Key player in fostering a collaborative and innovative team environment to drive continuous improvement and operational excellence.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The engineering professional we seek will possess these qualifications.

Basic Qualifications:

• High school diploma / GED and 10 years of Engineering and/or Operations experience; OR
• Associate’s degree and 8 years of Engineering and/or Operations experience; Or
• Bachelor’s degree and 4 years of Engineering and/or Operations experience; Or
• Master’s degree and 2 years of Engineering and/or Operations experience; Or
• Doctorate degree

Preferred Qualifications:

• Bachelor's degree in engineering or other science-related field with 7+ years of relevant work experience with 5+ years of experience in operations/manufacturing environment.
• Medical device industry experience and regulated work environment experience.
• A background in developing and commercialization of medical devices and knowledge of manufacturing processes.
• At a minimum familiar with the following standards and regulations: Quality System Regulation – 21CFR820, Risk Management – ISO 14971, EU Medical Device requirements – Council Directive 93/42/EEC.
• Strong understanding and experience in design controls, failure investigation, initiating and bringing complex projects to conclusion.
• Excellent communication and technical writing skills.
• Ability to work independently and across functional teams.
• Strong inter-personal and communication skills, with the ability to effectively collaborate with diverse teams and partners.
• Extensive knowledge of design controls and regulatory requirements for medical devices and combination products.
• Background in Combination product manufacturing processes and knowledge of developing and commercializing medical devices.
• Familiarity with standards and regulations such as Quality System Regulation – 21CFR820, Risk Management – ISO 14971, and EU Medical Device requirements – Council Directive 93/42/EEC.
• Strong understanding and experience in process failure investigation and project management.
• Preferably have technical flair and are familiar with technical drawings and construction.
• Demonstrated proficiency in project management.
• Preferably have Strong background in statistical analysis (experience wi