CQV Engineer - GMP Process Development

Amgen Inc.; New Albany (OH); On-site; USD 88,000 - 119,000; Full time

Benefits offered by this job

Stock-based incentives

Time-off plans

Flexible work models

Job summary

Amgen Inc. in Ohio is seeking an Engineer - Process Development (CQV) to support commissioning, qualification and validation of GMP equipment and processes for Final Drug Product operations at the Amgen Ohio site.

The role emphasizes technical transfer, startup readiness, data analysis and cross-functional collaboration across Manufacturing, Engineering and Quality. We expect a strong background in CQV, process validation and a proactive approach to continuous improvement, with travel around 20%

Qualifications

• Master’s degree in a relevant field.
• Bachelor’s degree and 2 years in a GMP-regulated environment.
• Associate’s degree and 6 years in a GMP-regulated environment.
• High school diploma / GED and 8 years in a GMP-regulated environment.
• Understanding of combination product assembly technologies and packaging operations.
• Experience supporting CQV activities, including protocol writing and data analysis.
• Excellent written and verbal communication; able to work in a team.
• Experience working with manufacturing equipment suppliers.
• Lean/Six Sigma exposure.

Responsibilities

• Commissioning, qualification and validation (CQV) of GMP equipment and processes.
• Support technical transfer of FDP and combination product processes.
• Collect and analyze process data to support validation and performance.
• Participate in project planning and cross-functional collaboration.
• Support documentation reviews and audits readiness.

Skills

CQV experience

Protocol writing

Data analysis

Cross-functional

Equipment suppliers

Education

Master’s degree in a relevant field

Bachelor’s degree + 2 years GMP

Associate’s degree + 6 years GMP

High school diploma / GED + 8 years GMP

Tools

IQ/OQ/PQ protocols

Job description

Amgen Inc. in Ohio is seeking an Engineer - Process Development (CQV) to support commissioning, qualification and validation of GMP equipment and processes for Final Drug Product operations at the Amgen Ohio site.

The role emphasizes technical transfer, startup readiness, data analysis and cross-functional collaboration across Manufacturing, Engineering and Quality. We expect a strong background in CQV, process validation and a proactive approach to continuous improvement, with travel around 20%