Lead Process Owner - Biotech Manufacturing

Amgen SA

Holly Springs (NC)

Presencial

USD 110 000 - 150 000

Tempo integral

14 dias+

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Resumo da oferta

Amgen is hiring for Specialist Manufacturing – Process Owner in Holly Springs, NC. The role spans Upstream, Downstream and Services with a focus on ownership of manufacturing processes, equipment, and unit operations.

You will provide floor support, troubleshoot issues, and assist with startup and first-time executions. The candidate should hold advanced biotech degrees with extensive GMP experience and strong technical writing skills.

Qualificações

Advanced degree with biotech operations experience.
Experience in GMP pharmaceutical manufacturing.
Ability to write and maintain GMP docs.

Responsabilidades

Serve as technical process owner for assigned manufacturing processes and equipment.
Provide floor support, troubleshooting, and hypercare during operations.
Support readiness activities including water/dry runs and EBR testing.
Collaborate with operations to ensure compliant, efficient execution.
Identify process optimization opportunities and risk reductions.
Participate in change controls and CAPA activities.
Translate processes into SOPs and workflows; support training material creation.
Assist in RCA investigations and quality events; support audits.