Sr. Process Development Engineer- Combination Products & Device Engineer
Amgen Inc
Senior Process Development Engineer position at Amgen's Ohio site leading combination products and device assembly technologies. The role combines device engineering expertise with process development to support commercialization, technology transfer, and continuous improvement of auto-injectors and other combination products in a cross-functional manufacturing environment.
Responsibilities
- Serve as site subject matter expert for combination products and automated assembly technologies
- Lead development, implementation, and optimization of automated product assembly equipment
- Support product commercialization, design transfer, and technology transfer into manufacturing
- Develop engineering studies, test methods, and protocols to support product development
- Lead root cause investigations and provide oversight for deviations and corrective actions
Requirements
- Advanced device engineering expertise with process development leadership experience
- Subject matter expertise in combination products, auto-injectors, or drug delivery devices
- Experience leading equipment implementation, validation, and manufacturing scale-up
- Proficiency with design controls, GMP requirements, and regulatory compliance standards
- Strong project management and cross-functional team leadership capabilities
- Experience with root cause analysis, CAPA implementation, and process optimization
Vacancy posted 5 days ago
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