Lead Process Owner - Biotech Manufacturing
Amgen SA
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Job summary
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.
Qualifications
- Advanced degree with biotech operations experience.
- Experience in GMP pharmaceutical manufacturing.
- Ability to write and maintain GMP docs.
Responsibilities
- 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.
Skills
Education
Tools
Job description
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.
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