Career Category

Supply Chain

Job Description

SUMMARY
The Senior Engineer position reports into the Senior Manager Engineering under Process Development.

This position requires the application of diverse and advanced engineering and scientific principles in support of commercial GMP Final Drug Product (FDP) operations for Amgen and it’s partners within the JAPAC region.

The position is expected to travel for approximately 10%.

FUNCTIONS
The Senior Engineer will support the development and implementation of technical solutions for a variety of engineering initiatives supporting the Amgen FDP product portfolio in the JAPAC region. 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, complex, 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.

OUTPUTS
Project Management
Key responsibilities will include leading the New Product Introduction (NPI) / Technical Transfer process for products to the JAPAC region.
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 stakeholders and deliver on technical improvements.

Technical Lead
Act as the subject matter expert lead for FDP products to the JAPAC region. 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.

RELATIONSHIPS
The Senior Engineer is expected to build and maintain a sustained professional relationship with Amgen’s manufacturing partner(s) in the JAPAC region to ensure our mission in serving our patients in this region.
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 leverage this network in support of the New Product Introduction/Technical Transfer process, and troubleshooting/process improvements.

JOB SPECIFICATIONS

• Master’s degree & 3 years of relevant job experience in a GMP environment

• Bachelors degree & 4 years of relevant job experience in a GMP environment

• Associate degree & 6 years of relevant job experience in a GMP environment

Competencies/Skills:

• Excellent written and verbal communication skills (Japanese & English) together with demonstrated ability to work in a team environment.

• Proven track record of leading and executing cross-functional projects.

• Strong team work, excellent interpersonal and communication skills.

• Direct experience with medical devices/combination products and associated manufacturing process.

• Experience of working with equipment suppliers.

• Ability to work in a highly regulated and ever changing industry.

• Ability to learn and rapidly adapt to new requirements in a fast moving environment.

• An Operational Excellence approach to work product . driving rapid results.

• A passion to deliver an excellent work product and develop others with an infective positive attitude!

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