Manufacturing Engineering Support - Process Improvement & NPI

BioSpace; New Albany (OH); On-site; USD 85,000 - 120,000; Full time

Benefits offered by this job

Retirement plan

Medical/dental/vision

Life and disability insurance

Bonus program

Stock-based incentives

Flexible time-off

Flexible work models

Job summary

Amgen is seeking a Sr. Associate - Manufacturing - Engineering Support to help execute manufacturing and quality systems, including continuous improvement, technology transfer, process validation, and CAPA activities.

You will apply technical and analytical skills to support operations, own process documentation, and participate in cross-functional teams for cost and cycle-time reductions while ensuring compliance and readiness for regulatory inspections.

Qualifications

• High school/GED + 4 years in Engineering, Manufacturing, Packaging or Quality experience in pharmaceutical, medical device or biotechnology companies.
• Associates + 2 years in Engineering, Manufacturing, Packaging or Quality experience in pharmaceutical, medical device or biotechnology companies.
• Bachelor's + 6 months in Engineering, Manufacturing, Packaging or Quality experience in pharmaceutical, medical device or biotechnology
• Master's degree in a related field is preferred for advanced roles.

Responsibilities

• Initiate, revise, and approve manufacturing procedures to reflect current operations.
• Assess process performance via floor observations and performance data; provide troubleshooting.
• Generate training materials and deliver training on scientific or technical aspects.
• Complete risk evaluations for new processes or changes and issue summary reports.
• Bring continuous improvement initiatives for cost reduction or cycle time reduction.
• Support process monitoring parameters and control limits; recommend improvements.
• Participate in technology transfer / NPI processes for documentation, training, and equipment changes.
• Assist with investigations, CAPA closures, and trend evaluations.
• Assist with process validation protocols and reports; analyze validation data.
• May participate in regulatory inspections and change control assessments.

Skills

Lean principles

Six Sigma

Operational Excellence

GMP knowledge

Data analysis

Problem solving

Cross-functional teams

Project management

Regulatory knowledge

Technical writing

Education

High school/GED

Associate's degree

Bachelor's degree

Master's degree

Tools

Documentation systems

Risk assessment tools

Job description

Amgen is seeking a Sr. Associate - Manufacturing - Engineering Support to help execute manufacturing and quality systems, including continuous improvement, technology transfer, process validation, and CAPA activities.

You will apply technical and analytical skills to support operations, own process documentation, and participate in cross-functional teams for cost and cycle-time reductions while ensuring compliance and readiness for regulatory inspections.