Sr Packaging Equipment Engineer- Process Development

Career Category

Process Development

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 Equipment Engineer- Process Development

What you will do

Let’s do this. Let’s change the world. In this role the Senior Engineer will support the development and implementation of technical solutions for a variety of engineering initiatives supporting the FDP product portfolio at Amgen AOH. The position is a key role in the Process Development group and the candidate must manage and/or apply extensive technical expertise in the coordination of multiple, sophisticated, non-routine projects involving the planning, design, reconfiguration, construction, maintenance, validation and alteration of systems, facilities and/or processes. This position will also be required to apply advance and diverse engineering principles to more than one area of engineering (process, unit operations, equipment, devices and materials) in complex process characterization, optimization, scale up or manufacturing support projects.

The Senior Engineer position reports into the Technology Lead under Process Development at the Amgen Ohio facility. This position requires the application of diverse and advanced engineering and scientific principles in support of commercial GMP Final Drug Product (FDP) operations in the Amgen Ohio manufacturing facility.

The position is expected to travel for approximately 25%

Key responsibilities will include leading the New Equipment and Technology Introduction, Technical Transfer process for products to AOH. Additional responsibilities will include the provision of technical operations support for the continuous improvement of packaging lines capacity and performance, and advisory of technical improvement projects. The Senior Engineer must ensure effective communication throughout the Amgen commercial site network with all collaborators and deliver on technical improvements.

Technical Lead

Act as the domain expert lead for FDP products to Amgen AOH. Be the technical expert for new process equipment and technology. The candidate is expected to use technical process knowledge and identify the required expertise to resolve process challenges as needed.

Operational Excellence

Responsible for supporting the delivery of productivity, throughput and general capacity improvements across AOH by analyzing, designing, and implementing manufacturing and business process improvements.

Relationships

The Senior Engineer is expected to build a network of FDP expertise across the Amgen commercial operations for product assembly, label and packaging. The position is expected to bring to bear this network in support of the New Product Introduction/Technical Transfer process, and trouble shooting/process improvements.

What we expect of you

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

Basic Qualifications:

Doctorate degree

or

Master’s degree & 2 years of engineering experience in a GMP environment

or

Bachelors degree & 4 years of engineering experience in a GMP environment

or

Associate degree & 8 years of engineering experience in a GMP environment

or

High School Diploma/GED & 10 years of engineering experience in a GMP environment

Preferred Qualifications:

• Excellent written and verbal communication skills together with demonstrated ability to work in a team environment.
• Track record of leading and driving multi-functional projects.
• Strong team work, excellent interpersonal and communication skills.
• Direct experience with medical devices/combination products and associated manufacturing process.
• Exper