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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.

Specialist Validation Engineer, Amgen Ohio (AOH) Manufacturing

Live

What you will do

Does the thought of building an entirely new site from the ground up excite you? Do you love cultivating sustainable systems and 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 Amgen's newest and most sophisticated final product assembly and packaging plant in New Albany, Ohio. When completed, the Amgen Final Product facility will combine the latest in robotic and automated technologies to allow for maximum operator efficiency in operations. The Final Product facility will not only feature the best in-class device 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.

Let’s do this. Let’s change the world. In this vital role the Senior Validation Engineer will serve as a technical lead/subject matter expert (SME) and lead the development and implementation of the Validation strategy at the Amgen Ohio (AOH) manufacturing facility. Specifically, this role has responsibility for developing and generating documents such as the site’s Validation Master Plan, validation plans, equipment qualification protocols/reports, among others.

• Provide technical support and domain expertise for commissioning, qualification, and validation maintenance activities in AOH
• Collaborate with project leads with direct accountability for project results related to validation outputs for commissioning and qualification of manufacturing process equipment
• Coordinate actions with Manufacturing, Engineering, Quality, and Supply Chain to ensure that the overall Amgen validation requirements are met
• Furnish technical assistance and represent validation for regulatory filings, audits, and inspections
• Ensure maintenance of site validation master plan and routine monitoring of validation status/regulatory compliance of equipment and systems
• Support site/network validation driven continuous improvement initiatives

Basic Qualifications

Doctorate degree

OR

Master’s degree and 3 years of Validation or Engineering experience

OR

Bachelor’s degree and 5 years of Validation or Engineering experience

OR

Associate’s degree and 10 years of Validation or Engineering experience

OR

High school diploma/GED and 12 years of Validation or Engineering experience

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.

• Proficient technical writing and presentations skills so as to collaborate with technical and senior management staff
• Expertise in equipment qualification for manufacturing facility
• Extensive experience in reviewing/approving validation protocols and reports in support of facility/equipment commissioning, qualification, and change administration
• Involvement in technical implementation of validation tasks associated with cleaning validation, steaming validation (including autoclaves) and controlled temperature chambers (CTC)
• Experience with SAFe and traditional Agile methodology coupled with strong GxP experience
• Knowledge of Regulations Eudralex Annex 15, FDA Title 21 CFR Part 210 and 211, Guidelines ASTM E2500 and ICH Q7
• Participation in supporting regulatory submissions, response to submission questions, pre-approval/biennial inspections, and observational response plans

Thrive

Some of the vast rewards of working here

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.

• 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

Apply now

for a career that defies imagination

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

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