Manufacturing Process Engineer: Drive Continuous Improvement

Biopharma Careers; New Albany (IN); On-site; USD 108,000 - 146,000; Full time

Benefits offered by this job

Retirement plan

Comprehensive medical/dental/vision

Life and disability insurance

Stock-based incentives

Flexible time-off

Job summary

Amgen is seeking a Manufacturing Specialist to support execution of manufacturing and quality systems. The role involves process validation, technology transfer, and continuous improvement to ensure compliant operations. You will contribute to risk assessments, training, and CAPA activities while collaborating with diverse teams.

The position emphasizes regulatory readiness, change control, and data-driven decision making to sustain safe, high-quality therapeutics for patients.

Qualifications

• Doctorate or Master's degree with relevant experience in pharma/biotech manufacturing.
• Bachelor's with 4+ years in engineering/manufacturing/quality in pharma/biotech.
• Associate's with 8+ years in engineering/manufacturing/quality in pharma/biotech.
• High school diploma with 10+ years in relevant field.

Responsibilities

• Execute manufacturing/quality systems including continuous improvement and technology transfer.
• Support process validation, risk assessments, training, and non-conformance handling.
• Lead or support technology transfer, new product introductions, and process modifications.
• Oversee CAPA investigations and trend analysis; ensure timely closeout.

Skills

Lean principles

Six Sigma

Kaizen

Cross-functional teamwork

Regulatory knowledge

Project management

Quality mindset

Analytical skills

Education

Doctorate degree

Master’s degree + 2 years in Engineering, Manufacturing, Packaging or Quality in pharma/biotech

Bachelor’s degree + 4 years in Engineering, Manufacturing, Packaging or Quality in pharma/biotech

Associate’s degree + 8 years in Engineering, Manufacturing, Packaging or Quality in pharma/biotech

High school diploma / GED + 10 years in Engineering, Manufacturing, Packaging or Quality in pharma/biotech

Job description

Amgen is seeking a Manufacturing Specialist to support execution of manufacturing and quality systems. The role involves process validation, technology transfer, and continuous improvement to ensure compliant operations. You will contribute to risk assessments, training, and CAPA activities while collaborating with diverse teams.

The position emphasizes regulatory readiness, change control, and data-driven decision making to sustain safe, high-quality therapeutics for patients.