Senior Manufacturing Process Engineer, Engineering Support

Amgen SA; New Albany (OH); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Total Rewards Plan

Stock-based incentives

Flexible work models

Retirement and Savings Plan

Job summary

Amgen seeks a Sr. Associate - Manufacturing - Engineering Support to help execute manufacturing and quality systems across ongoing operations in New Albany, OH.

You will apply process, operational, and scientific expertise to support tech transfer, validation, and continuous improvement activities. You will own documentation updates, perform risk assessments, and assist with CAPA investigations, regulatory interactions, and change control while collaborating with cross-functional teams to drive

Qualifications

• High school/GED + 4 years in engineering, manufacturing, packaging or quality in pharma/biotech.
• Associate’s + 2 years in engineering, manufacturing, packaging or quality in pharma/biotech.
• Bachelor’s + 6 months in engineering, manufacturing, packaging or quality in pharma/biotech.
• Master's degree holders qualify for the role.
• Knowledge of Lean, Kaizen, Six Sigma and operational excellence preferred.
• Experience with cross-functional teams and change control processes.
• Strong GMP production operations knowledge and regulatory awareness.

Responsibilities

• Execute manufacturing/quality systems such as continuous improvement, technology transfer, NPI, and process validation.
• Maintain procedures reflecting current operations; perform risk evaluations and training.
• Support tech transfer and NPI for docs, training, equipment modifications.
• Participate in cost/time reduction initiatives and special projects.
• Assist with CAPA/NC investigations and trend evaluations.
• Support regulatory inspections and CCRB-related activities.
• Provide training materials and deliver technical trainings.

Skills

Lean principles

Six Sigma

GMP operations

Regulatory knowledge

Data analysis

Project management

Cross-functional collaboration

Technical writing

Process validation

Education

High school/GED with 4 years in Eng, Manufacturing, Packaging or Quality

Associate’s + 2 years in Eng, Manufacturing, Packaging or Quality

Bachelor’s + 6 months in Eng, Manufacturing, Packaging or Quality

Master's

Job description

Amgen seeks a Sr. Associate - Manufacturing - Engineering Support to help execute manufacturing and quality systems across ongoing operations in New Albany, OH.

You will apply process, operational, and scientific expertise to support tech transfer, validation, and continuous improvement activities. You will own documentation updates, perform risk assessments, and assist with CAPA investigations, regulatory interactions, and change control while collaborating with cross-functional teams to drive