CQV Engineer: Process Development & Validation

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

Benefits offered by this job

Bonus program

Stock‑based incentives

Flexible work models

Benefits package

Job summary

Amgen Ohio site is seeking a Process Development Engineer to lead CQV activities for FDP equipment and processes. You will drive commissioning, qualification, and validation across automated packaging and assembly, ensuring compliant, reliable production.

The role emphasizes technical transfer, data analysis, and continuous improvement within a GMP framework. You will partner with Manufacturing, Process Development, Engineering, and Quality to meet deliverables, participate in inspections, and

Qualifications

• Master’s degree required.
• 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.

Responsibilities

• Commissioning, Qualification & Validation (CQV) complete commissioning activities and author/implement IQ/OQ/PQ protocols, validation plans, and lifecycle documentation.
• Maintain validated state of equipment and processes through periodic review and documentation updates.
• Support and participate in FAT/SAT, equipment installation, and startup readiness.
• Provide technical feedback into change control, deviations, CAPA, and risk assessments (as applicable to validation activities).
• Project Management & Multi‑Functional Collaboration CQV project planning, schedule alignment, and execution.

Education

Master’s degree

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

Job description

Amgen Ohio site is seeking a Process Development Engineer to lead CQV activities for FDP equipment and processes. You will drive commissioning, qualification, and validation across automated packaging and assembly, ensuring compliant, reliable production.

The role emphasizes technical transfer, data analysis, and continuous improvement within a GMP framework. You will partner with Manufacturing, Process Development, Engineering, and Quality to meet deliverables, participate in inspections, and