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Principal Validation Engineer at Amgen - ApplyBlast

Principal Validation Engineer

Amgen

1 month ago

3.6 on Glassdoor

Singapore, Singapore, Singapore

Onsite

Full Time

Senior

0 applicants

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About this role

The Principal Validation Engineer oversees validation strategies and documents for Synthetic Drug Substance and Biologic Aseptically Filled Drug Product manufacturing at contract sites. This role ensures compliant process and cleaning validation strategies while collaborating with global quality teams and cross-functional project teams. The position involves risk assessment, validation document approval, and supporting tech transfers and new product introductions.

Responsibilities

Oversee validation strategies and documents for synthetic drug substance and biologic drug product
Ensure compliant process and cleaning validation strategies at contract manufacturing organizations
Review and approve validation documentation, deviations, and master batch records

Skills

About Amgen

amgen.com

Headquarters

Thousand Oaks, California, United States

Company Size

10001+ employees

Founded

1980

View Profile

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