Senior Process Engineer - Combination Products & Devices

Amgen; New Albany (OH); On-site; USD 120,000 - 160,000; Full time

Job summary

Amgen Ohio site is seeking a Sr. Process Development Engineer—Combination Products & Device Engineer to lead advanced device engineering and process development for combination products and auto-injectors.

You will drive technology transfer, lifecycle management, and continuous improvement across commercial operations. You will collaborate across device engineering, manufacturing, quality, regulatory affairs, and external partners to ensure compliant, effective manufacturing and product

Qualifications

• Doctorate or equivalent required in engineering or related field.
• Master's degree with 2+ years of GMP-regulated engineering/operation experience.
• Bachelor's degree with 4+ years GMP experience.
• Associate's degree with 8+ years GMP experience.
• High school diploma with 10+ years GMP experience.

Responsibilities

• Serve as site SME for combination products and auto-injectors.
• Lead development and optimization of automated assembly equipment.
• Support product commercialization, design transfer, and technology transfer.
• Develop engineering studies, characterization plans, test methods, protocols, and reports.
• Analyze engineering data to evaluate product performance and process capability.
• Provide technical support for device assembly, labeling, packaging, manufacturing scale-up.
• Lead root-cause investigations and CAPA implementation.
• Coordinate technical activities with equipment suppliers and internal partners.

Skills

Leadership

Project management

Communication

Cross-functional collaboration

Education

Doctorate degree

Master's degree + 2 years GMP experience

Bachelor's degree + 4 years GMP experience

Associate's degree + 8 years GMP experience

High school diploma + 10 years GMP experience

Tools

SolidWorks

CAD drawings

DOE

SPC

FMEA

Regulatory knowledge

Job description

Amgen Ohio site is seeking a Sr. Process Development Engineer—Combination Products & Device Engineer to lead advanced device engineering and process development for combination products and auto-injectors.

You will drive technology transfer, lifecycle management, and continuous improvement across commercial operations. You will collaborate across device engineering, manufacturing, quality, regulatory affairs, and external partners to ensure compliant, effective manufacturing and product