Biotech Manufacturing Process Engineer - Drive Improvements

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

Benefits offered by this job

Retirement plan

Medical, dental, and vision coverage

Stock-based incentives

Flexible work models where possible

Job summary

Amgen is seeking a Manufacturing Specialist to join our Ohio operations, where you will support manufacturing and quality systems across continuous improvement, technology transfer, and process validation. You will apply scientific expertise to optimize procedures, assess performance, and implement improvements with cross-functional teams.

You will own process systems, participate in risk evaluations, and help generate training materials while ensuring compliance with regulatory requirements.

Qualifications

• Doctorate or equivalent experience in engineering, manufacturing, packaging or quality in pharma/biotech.
• Advanced knowledge of process validation, CAPA, quality systems.
• Strong written and verbal communication skills for regulatory and team collaboration.
• Experience with change control processes and cross-functional project support.
• Lean Six Sigma and problem-solving methodologies are preferred.

Responsibilities

• Support manufacturing/quality systems including continuous improvement and technology transfer.
• Lead process ownership for process systems and assist with ownership responsibilities.
• Perform risk evaluations and generate summary reports for new processes or changes.
• Drive cost reduction and cycle time improvement through continuous improvement initiatives.
• Assist with process validation protocols and reports, and support data analysis for deviations.

Skills

Lean Six Sigma

Cross-functional teams

GMP operations

Regulatory knowledge

Project management

Data analysis

Change control

Process improvement

Technical writing

Collaboration

Education

Doctorate degree

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

Bachelor’s degree +4 years in Eng, Manufacturing, Packaging or Quality

Associate’s degree +8 years in Eng, Manufacturing, Packaging or Quality

High school diploma / GED +10 years in Eng, Manufacturing, Packaging or Quality

Job description

Amgen is seeking a Manufacturing Specialist to join our Ohio operations, where you will support manufacturing and quality systems across continuous improvement, technology transfer, and process validation. You will apply scientific expertise to optimize procedures, assess performance, and implement improvements with cross-functional teams.

You will own process systems, participate in risk evaluations, and help generate training materials while ensuring compliance with regulatory requirements.