Biotech Manufacturing Operator: Cleanroom & Equipment Ops

Amgen SA; Thousand Oaks, Northern (CA, KY); Hybrid; USD 85,000 - 110,000; Full time

Benefits offered by this job

Retirement and Savings Plan

Medical, dental, and vision coverage

Stock-based incentives

Flexible work models where possible

Job summary

Amgen in Thousand Oaks, CA, is seeking an Associate Manufacturing professional to support preparation, start-up, and commercial manufacturing of Epogen Drug Substance Intermediate (DSI) in Building 7. You will operate in cleanroom environments and help ensure product supply and safety.

The role requires a background in manufacturing operations, training staff, and ensuring compliance with CFR and regulatory standards, with opportunities for technical growth and contribution to continuous

Qualifications

• Bachelor’s degree or higher in life sciences or engineering.
• Associate’s degree with 6 months of manufacturing and operations experience.
• High school diploma or GED with 2 years of manufacturing and operations experience.

Responsibilities

• Operate in classified cleanroom environments (Grade 9 through Grade 5) per SOPs.
• Set-up, CIP, and SIP of production equipment.
• Operate equipment on the production floor following SOPs.
• Monitor manufacturing processes and escalate issues to management.
• Support facilities and engineering in testing and operation of manufacturing equipment.
• Train staff on operation of manufacturing equipment.
• Support commissioning and qualification of new equipment.
• Drive continuous improvement within the building.
• Escalate to management when safety, equipment, product supply, or quality is at risk.
• Champion safety and compliance at all times.
• Review and revise procedures and forms.
• Coordinate improvement projects.
• Own and manage Minor Deviations, ensuring on-time closure.

Job description

Amgen in Thousand Oaks, CA, is seeking an Associate Manufacturing professional to support preparation, start-up, and commercial manufacturing of Epogen Drug Substance Intermediate (DSI) in Building 7. You will operate in cleanroom environments and help ensure product supply and safety.

The role requires a background in manufacturing operations, training staff, and ensuring compliance with CFR and regulatory standards, with opportunities for technical growth and contribution to continuous