Senior Validation Engineer
Amgen(1 month ago)
About this role
A Senior Validation Engineer at Amgen ensures supply of high-quality medicines by overseeing validation strategies and documentation for finished drug products at contract manufacturing organizations, primarily in the JAPAC region. The role emphasizes qualification of primary and secondary packaging, device/combination products, and may include synthetic API and aseptic processes. The position works closely with global quality and manufacturing teams and requires travel to CMOs including Japan.
Required Skills
- Process Validation
- Packaging Processes
- Device Qualification
- Statistical Methods
- API Validation
- Aseptic Processing
- Cleaning Validation
- Tech Transfer
- Regulatory Compliance
- Risk Assessment
+2 more
Qualifications
- Doctorate Degree
- Master's Degree
- Bachelor's Degree
- Diploma
About Amgen
amgen.comAmgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics.
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