Process Development Engineer

Responsibilities

• Lead process development, optimization, and scale-up activities for downstream manufacturing processes.
• Apply statistical tools and data analytics to evaluate process performance and support data-driven decision-making.
• Author and review technical reports, protocols, study plans, and development documentation.
• Support technology transfer activities between development, pilot, and manufacturing facilities.
• Collaborate with Manufacturing, Quality, Regulatory, and Supply Chain teams to resolve technical issues.
• Support process validation and continued process verification activities.
• Identify opportunities for process improvements to enhance product quality, yield, and operational efficiency.
• Ensure compliance with all applicable GMP, safety, and quality requirements.

Requirements

• Master's degree in Engineering OR a Bachelor's degree in Engineering with 2+ years of relevant experience.
• Experience in the biotechnology or pharmaceutical industry.
• Familiarity with GMP regulations and industry guidance.
• Proficiency with statistical software such as JMP, Minitab, MATLAB, Python, or Spotfire.
• Strong technical writing and presentation skills.

Preferred Qualifications

• Bachelor's degree in Chemical Engineering, Biochemical Engineering, Bioengineering, Biotechnology, or Mechanical Engineering.
• Experience in manufacturing sciences, technical operations, or process engineering.
• Proven ability to work effectively in cross-functional and matrixed environments.

Benefits

• Comprehensive health and welfare plans, including medical, dental, and vision coverage.
• Retirement and Savings Plan with generous company contributions.
• Discretionary annual bonus program and stock-based long-term incentives.
• Award-winning time-off plans.

About the Company

Amgen is a leading biotechnology company dedicated to serving patients living with serious illnesses. Since 1980, we have pioneered advancements in oncology, inflammation, general medicine, and rare diseases by leveraging human genetics and biologics manufacturing expertise to deliver innovative medicines worldwide.