Senior Process Engineer - CIP/SIP/Autoclaves
Amgen Inc
Senior Process Engineer position supporting design, commissioning, and operational management of CIP, SIP, and autoclave systems at a new advanced drug substance manufacturing facility. Role involves lifecycle equipment support, troubleshooting, regulatory compliance, and continuous improvement initiatives across interconnected process systems.
Responsibilities
- Design and support build of manufacturing equipment systems with alignment to site requirements and engineering standards
- Execute commissioning and validation of CIP, SIP, and autoclave systems ensuring GMP compliance and operational readiness
- Serve as system owner providing end-to-end operational support and troubleshooting for process equipment areas
- Lead identification and implementation of equipment improvements and modifications to reduce production downtime
- Develop master maintenance programs, manage spare parts availability, and coordinate preventive maintenance activities
Requirements
- Doctorate degree OR Master's degree with 2+ years engineering experience OR Bachelor's degree with relevant experience
- Domain expertise in CIP skids, SIP circuits, autoclaves, and associated instrumentation systems
- Experience with equipment design, factory acceptance testing, and commissioning processes
- Knowledge of GMP regulations, validation protocols, and manufacturing compliance requirements
- Strong problem-solving and root cause analysis capabilities for equipment systems
- Ability to collaborate with manufacturing, quality, maintenance, and cross-functional teams
Vacancy posted 1 day ago
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