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Job Description

HOW MIGHT YOU DEFY IMAGINATION?

You’ve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge you’ve worked hard to acquire and the passion you already have. 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. Become the professional you are meant to be in this meaningful role.

“Does the thought of building an entirely new site from the ground up excite you? Do you love building and developing high performing teams? If you have a passion for talent development and want to be a part of Amgen’s mission to serve patients – every patient every time – then check out this exciting new opportunity.

Be part of the Amgen Advanced Assembly and Final Product Operation, a new facility focused on medical device assembly and packaging of injectable medicines. When completed, the Advanced Assembly and Final Product Operation facility will not only feature the best in-class assembly and packaging technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen’s plan to be a carbon-neutral company by 2027.”

Senior Engineer-Validation

The Senior Engineer-Validation position reports into the Senior Manager Engineering 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%.

Live

What you will do

Let’s do this. Let’s change the world. In this vital role the Senior Engineer-Validation will support the development and implementation of all Commissioning, Qualification and Validation (CQV) of all GMP equipment and processes at the Amgen AOH facility. 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.

The Senior Engineer Validation will complete this via planning, implementing and monitoring the risk-based validation strategy, which can be followed via the created documented evidence trail. Within the Amgen AOH facility this entails introduction of new products, new secondary packaging technology and cold chain activities.

Outputs

CQV (Commissioning, Qualification and Validation)

• Lead and support the execution of validation strategy tasks.
• Perform periodic validation reviews.
• Develop and execute validation protocols.
• Complete the CQV deliverables of projects within schedule, budget and quality constraints.
• Work with other disciplines for large and/or highly complex process, system and facility modifications.

Relationships

The Senior Engineer Validation is expected to build a network of FDP CQV expertise across the Amgen commercial operations for product assembly, label and packaging.

Win

What we expect of you

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

Minimum Requirements

Education/License:

• Doctorate degree
• Master’s degree & 3 years of relevant job experience in a GMP environment
• Bachelors degree & 5 years of relevant job experience in a GMP environment
• Associate degree & 10 years of relevant job experience in a GMP environment

Competencies/Skills:

• Excellent written and verbal communication skills 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.
• Knowledge of regulations Eudralex Annex 15, FDA CFR 11, 210 and 211.
• Knowledge of guidelines GAMP5, ASTM E2500, ICH.
• 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!

Thrive

Some of the vast rewards of working here

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

• Full support and career-development resources to expand your skills, enhance your expertise, and maximize your potential along your career journey
• A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
• Generous Total Rewards Plan—comprising health, finance and wealth, work/life balance, and career benefits—with compensation and benefits rated above 4 stars (out of 5) on Glassdoor

#AmgenOhio

Apply now

for a career that defies imagination

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

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