Manufacturing Process Engineer — Lean & GMP Focus

Amgen; New Albany (OH); On-site; USD 108,000 - 146,000; Full time

Benefits offered by this job

Competitive benefits package

Stock-based incentives

Flexible work models

Retirement plan

Job summary

Amgen Inc. (IR) is hiring a Manufacturing Specialist-Process Engineer to drive process improvements, validation, and technology transfer in a US Ohio facility.

You will own process-related procedures and support quality systems, risk assessments, and training development. Ideal candidates bring advanced degrees or equivalent experience in engineering, plus 2+ years in pharmaceutical/biotech operations, with Lean/Six Sigma and GMP knowledge.

Qualifications

• Advanced knowledge of bioprocessing and manufacturing operations.
• Experience with Lean principles and problem-solving techniques.
• Strong written and verbal communication, with technical report writing skills.

Responsibilities

• Lead and support manufacturing/quality systems projects, including process validation and tech transfer.
• Develop and implement process improvements to reduce cycle time and cost.
• Maintain process documentation, training materials, and change controls.
• Support CAPA investigations and closure within established timelines.
• Collaborate with cross-functional teams across manufacturing, development, and quality.

Skills

Process engineering

Lean Six Sigma

GMP

Regulatory knowledge

Project management

Cross-functional collaboration

Education

Doctorate degree

Master's degree in Engineering

Bachelor's degree in Engineering

Associate’s degree in Engineering

Job description

Amgen Inc. (IR) is hiring a Manufacturing Specialist-Process Engineer to drive process improvements, validation, and technology transfer in a US Ohio facility.

You will own process-related procedures and support quality systems, risk assessments, and training development. Ideal candidates bring advanced degrees or equivalent experience in engineering, plus 2+ years in pharmaceutical/biotech operations, with Lean/Six Sigma and GMP knowledge.