Sr. Engineer (Combination Product Device Assembly)

Career Category

Engineering

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

You’ve 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—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.

Sr Engineer- Combination Product Device Assembly

Live

What you will do

Let’s do this. Let’s 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 Assembly and Packaging of combination products at the Amgen Ohio facility.

The Senior Engineering 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 (automated device assembly, labeling, cartoning, etc.) 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 Senior Engineering 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:

Doctorate degree

OR

Master’s degree and 3 years of technical operations or combination device assembly experience

Or

Bachelor’s degree and 5 years of technical operations or combination device assembly experience

Or

Associate’s degree and 10 years of technical operations or combination device assembly experience

Or

High school diploma / GED and 12 years of technical operations or combination device assembly experience

Preferred Qualifications:

• Knowledge of combination product assembly equipment, labeling, cartoning and applicable testing.
• Excellent written and verbal communication together with the ability to work in a collaborative environment.
• Track record of leading and performing dynamic projects.
• Strong team work and excellent interpersonal communication.
• Direct experience with the manufacturing process for devices, combination products and label & packaging operations.
• Experience of working with  combination product 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 paced environment.
• An Operational Excellence approach to work product – driving rapid results.
• A desire to deliver an excellent work product and develop others with an infective positive demeanor!

Thrive

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.

The annual base salary range for this opportunity in the U.S. is $111,913 -$132,048.

In addition to the base salary, Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:

• Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans and bi-annual company-wide shutdowns
• Flexible work models, including remote work arrangements, where possible

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

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Salary Range

111,913.00 USD - 132,048.00 USD