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Process Analytical Engineer at Amgen - ApplyBlast

Process Analytical Engineer

Amgen

3 months ago

3.6 on Glassdoor

Holly Springs, North Carolina

Hybrid

Full Time

Senior

0 applicants

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About this role

As a Process Analytical Engineer at Amgen, you will ensure the qualification, calibration, and routine maintenance of cGMP Quality Control laboratory facilities while supporting manufacturing operations to maximize equipment uptime. The role involves authoring validation life cycle documents, troubleshooting analytical systems, and leading development of laboratory equipment specifications and maintenance programs. You will act as a subject matter expert on instrument validation regulations, participate in technical project teams, and support new product introductions with engineering assessments.

Responsibilities

Plan and execute qualification and calibration of laboratory systems
Author and approve validation life cycle documents for computer systems
Lead development of calibration and maintenance programs
Collaborate with manufacturing teams to resolve system issues
Participate in technical projects as a subject matter expert

Skills

Qualifications

Master's degreeBachelor's degreeAssociate's degreecGMP Laboratory ExperienceAnalytical Instrument Validation Experience

About Amgen

amgen.com

Headquarters

Thousand Oaks, California, United States

Company Size

10001+ employees

Founded

1980

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Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics.