amgen
amgen11d ago
New

Specialist Manufacturing – Process Owner - Upstream / Downstream / Services

Us - North Carolina - Holly Springsmid
OtherManufacturing
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Quick Summary

Key Responsibilities

Upstream Manufacturing, Downstream Manufacturing, or Manufacturing Services (Raw Material Dispensing and Solution Preparation).

Technical Tools
OtherManufacturing
Manufacturing

Responsibilities

~1 min read
  • Doctorate degree and 2 years of biotechnology operations experience OR

  • Master's degree in Engineering, Biology, Chemistry, Biochemistry, or related field and 4 years of biotechnology operations experience OR 

  • Bachelor's degree and 6 years of biotechnology operations experience OR 

  • Associate's degree and 10 years of biotechnology operations experience OR 

  • High school diploma / GED and 12 years of biotechnology operations experience 

Requirements

~1 min read
  • Technical expertise in Upstream Manufacturing, Downstream Manufacturing, or Manufacturing Services (Raw Material Dispensing and Solution Preparation). 

  • Strong technical knowledge of drug substance manufacturing processes, equipment, and unit operations. 

  • Experience supporting GMP manufacturing operations in a biotechnology or pharmaceutical environment. 

  • Experience supporting manufacturing floor operations, troubleshooting, and hypercare activities. 

  • Experience supporting operational readiness activities including water runs, dry runs, equipment testing, and startup support. 

  • Experience authoring and maintaining GMP documentation including SOPs and manufacturing procedures. 

  • Experience supporting manufacturing change controls and implementation activities. 

  • Experience participating in risk assessments, root cause analyses, investigations, and CAPA implementation activities. 

  • Experience supporting CAPA applicability assessments and effectiveness checks. 

  • Experience supporting Manufacturing Execution Systems (MES) and Electronic Batch Records (EBRs) within a GMP manufacturing environment. 

  • Knowledge of single-use technologies and Bill of Material (BOM) structures. 

  • Strong technical writing, communication, problem-solving, and organizational skills. 

What We Offer

~1 min read
107,545.40USD -145,502.60 USD

Location & Eligibility

Where is the job
Us - North Carolina - Holly Springs
On-site at the office
Who can apply
Open to applicants worldwide

Listing Details

Posted
July 11, 2026
First seen
July 16, 2026
Last seen
July 21, 2026

Posting Health

Days active
0
Repost count
0
Trust Level
28%
Scored at
July 16, 2026

Signal breakdown

freshnesssource trustcontent trustemployer trust
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amgenSpecialist Manufacturing – Process Owner - Upstream / Downstream / Services