Career Category Engineering
HOW MIGHT YOU DEFY IMAGINATION?
You\xe2\x80\x99ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission\xe2\x80\x94to serve patients\xe2\x80\x94drives all that we do. It is key to our becoming one of the world\xe2\x80\x99s leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.
Engineer- Combination Product Device Assembly
Live
What you will do
Let\xe2\x80\x99s do this. Let\xe2\x80\x99s change the world. In this role The Senior Engineer position reports into the Sr, Manager of 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 in the Amgen Ohio facility.
The Engineer will support the development and implementation of automated and semi-automated combination product assembly equipment initiatives as part of the Finished Drug Product (FDP) product portfolio at the Amgen Ohio manufacturing site. The position is a key role in the Process Development team where the candidate must manage and/or apply extensive technical expertise (characterization, validation and trouble shooting) in the assembly of combination products. 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 optimization, scale up and manufacturing support projects.
Project Management
Key responsibilities will include supporting the Technical Transfer of the Amgen product portfolio to AOH. Additional responsibilities will include the provision of technical operations support for the continuous improvement of device assembly and packaging line capacity and performance, and advisory of technical improvement projects. The Sr. Engineer must ensure effective communication throughout the Amgen Ohio commercial site and Amgen network with all partners and deliver on technical deliverables.
Technical Lead
Act as the site technical expert for automated and semi-automated device assembly for FDP and non-combination products. Be the technical expert for new process and existing device assembly technology. The candidate is expected to use technical process knowledge and identify the required expertise to resolve process challenges as needed. Technical expertise in combination product assembly is required.
The candidate will also lead the Commissioning, Qualification and Validation of process and GMP equipment located at AOH. They will own the site master validation plan for GMP equipment and will be responsible to the maintenance and execution of this.
Operational Excellence
Responsible for supporting the delivery of productivity, throughput and general capacity improvements across the AOH site by analyzing, designing, and implementing manufacturing and business process improvements.
Relationships
The Engineer is expected to build a network of FDP expertise across the Amgen commercial and clinical operations for product assembly, label and packaging. The position is expected to bring to bear this network in support of GMP technical expertise, performance trending, equipment standardization and trouble shooting/process improvements at AOH.
Win
What we expect of you
We are all different, yet we all use our outstanding contributions to serve patients. The engineering professional we seek will possess these qualifications.
Basic Qualifications:
Master\xe2\x80\x99s degree
Or
Bachelor\xe2\x80\x99s degree and 2 years of technical operations or combination device assembly experience
Or
Associate\xe2\x80\x99s degree and 6 years of technical operations or combination device assembly experience
Or
High school diploma / GED and 8 years of technical operations or combination device assembly experience
Preferred Qualifications:
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