Manufacturing Process Engineer: Lean & Tech Transfer

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

Benefits offered by this job

Discretionary annual bonus program

Stock-based long-term incentives

Retirement and savings plan

Flexible work model

Job summary

Amgen Specialist, Manufacturing role focused on executing manufacturing and quality systems, supporting continuous improvement, technology transfer and process validation. You will apply technical expertise to ensure compliant operations, training, and data-driven decision making.

The role emphasizes process ownership, CAPA, change control, and collaboration with cross-functional teams to drive efficiency and quality across manufacturing lines.

Qualifications

• Doctorate or Master’s with 2 years in Engineering, Manufacturing, Packaging or Quality in pharma/biotech; or Bachelor’s with 4 years; or Associate’s with 8 years; or high school with 10 years.
• Detailed technical understanding of bio-processing and manufacturing operations.
• Experience with Lean principals (Kaizen, Six Sigma) and problem-solving.
• Experience in cross-functional teams, GMP production operations, and regulatory interactions.

Responsibilities

• Apply process expertise: author and revise manufacturing procedures; assess performance; troubleshoot and improve processes.
• Lead continuous improvement initiatives for cost/cycle time reductions.
• Monitor processes and support deviations, quarterly reports, and data reviews.
• Assist technology transfer and NPI processes, documenting requirements and coordinating training.
• Support change control records and root-cause analyses for investigations.
• Assist process validation and regulatory inspections as needed.

Skills

Lean principles

Problem solving

Cross-functional collaboration

GMP knowledge

Project management

Data analysis

Regulatory knowledge

Education

Doctorate degree

Master’s degree

Bachelor’s degree

Associate’s degree

High school diploma / GED

Job description

Amgen Specialist, Manufacturing role focused on executing manufacturing and quality systems, supporting continuous improvement, technology transfer and process validation. You will apply technical expertise to ensure compliant operations, training, and data-driven decision making.

The role emphasizes process ownership, CAPA, change control, and collaboration with cross-functional teams to drive efficiency and quality across manufacturing lines.