Process Engineer - CIP/ SIP/ Autoclave
Amgen Inc
Amgen seeks a Process Engineer to support design, commissioning, and qualification of CIP, SIP, and autoclave systems for a new advanced drug substance manufacturing facility in North Carolina. The role involves lifecycle technical support, regulatory compliance, and operational readiness across manufacturing systems.
Responsibilities
- Support commissioning and qualification of CIP, SIP, and autoclave systems per GMP requirements
- Provide technical expertise and lifecycle support for manufacturing equipment and associated automation
- Interact with regulatory inspectors to demonstrate compliance of operating systems
- Develop equipment maintenance programs and coordinate maintenance activities
- Assist with new product introductions through engineering assessments and equipment modifications
Requirements
- Master's degree OR Bachelor's degree with 2+ years engineering experience
- Bachelor's degree in Chemical, Mechanical, or related engineering discipline (preferred)
- 3+ years relevant experience, including 2+ years in biopharmaceutical operations/manufacturing
- Direct knowledge of GMP biopharmaceutical production equipment design and troubleshooting
- Experience with CIP circuit design/validation, SIP systems, and autoclaves
- Familiarity with regulated environments (cGMP, OSHA, EPA) and GMP quality systems
- Data-driven problem-solving skills (Root Cause Analysis, Statistical Process Control, Six Sigma)
Vacancy posted 9 days ago
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