Sr. Packaging Engineer

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.

Sr. Packaging Engineer

What you will do

Let’s do this. Let’s change the world. This position reports into the Packaging Engineering group under Combination Product Operations (CPO) in Amgen Ohio (AOH). The position will support global supply, new product introductions, partnerships/acquisitions and combination products. This position applies physics, engineering and chemistry principles coupled with advanced and diverse materials science understanding and principles to assist in the evaluation, design, qualification and implementation of packaging components and the associated systems such as documentation, equipment and processes. A knowledge of common materials used in pharmaceutical packaging is key to this role. This role will support Amgen’s manufacturing network by applying broad knowledge of pharmaceutical packaging operations, equipment, devices, and materials to develop the industry’s best combination product assembly and packaging processes. Understanding of packaging manufacturing equipment and processes and how materials interact with these are essential to the position. The job will require both planning and technical support of complex projects supporting a new site start-up. This role will be responsible for planning and coordinating projects to ensure on-time completion, establish priorities, report project status updates, and manage project dashboards for the Secondary Packaging Engineering team. This role will have some entry level management potential and the successful candidate will also apply excellent organizational, project management, technical problem solving and communication (written and verbal) skills, with the ability to work in teams and adapt to a rapidly changing environment. Project Management experience supporting implementation of commercial packaging configurations is preferred. Candidate must possess extensive knowledge and expertise in the use of project management methodologies and tools.

Responsibilities:

This position is responsible and accountable for the following:

• Project Management of entry level engineers and contingent workers
• Evaluation, recommendation and selection of new secondary packaging materials for pharmaceutical products
• Assessing complex problems relating to materials, recommending and implementing solutions
• Write test protocols, perform technical evaluations and submitting technical assessment reports to justify the use of selected materials
• Write Technical Specifications
• Representing Final Product Technologies as required
• Technology transfer from clinical to commercial or from site to site for packaging components and equipment processes
• Establish priorities to ensure all projects are managed within expected due dates
• Lead and present new packaging ideas, concepts and design ideas to the Product Development team
• Ensures cGMP and regulatory compliance are met
• Ensures that change control procedures are followed working with QA and Regulatory to implement changes
• Participants in Pre-Approval Inspections (PAI) and interact with regulatory bodies (e.g., FDA, EMEA, etc.) as needed
• Collaborates with cross-functional teams (i.e. Research, QA/QC, Supply
• Chain, Maintenance, Manufacturing, Regulatory, etc.) in pre-commercial and commercial activities

What we expect of you

We are all different, yet we all use our outstanding contributions to serve patients. The dynamic professional we seek is an individual with these qualifications.

Basic Qualifications:

Doctorate degree in Packaging Engineering, Materials Science, Mechanical Engineering, Chemical Engineering, or related engineering field

Or

Master’s degree in Packaging Engineering, Materials Science, Mechan