CQV Engineer: Process Development & Validation

Amgen SA; New Albany (OH); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Retirement plan

Stock incentives

Flexible work arrangements

Job summary

Amgen Ohio is seeking an Engineer - Process Development (CQV) to support commissioning, qualification, and validation of GMP equipment and processes enabling FDP operations. You will contribute to technical transfer, equipment startup, and continuous improvement across packaging and assembly operations.

The role requires a Master’s degree or equivalent GMP-regulated experience, with additional qualifications in CQV and cross-functional project management. Travel may be required.

Qualifications

• Master’s degree or higher required in a relevant field.
• Bachelor’s degree with 2+ years GMP-regulated experience.
• Associate’s degree with 6+ years GMP-regulated experience.
• High school diploma or GED with 8+ years GMP-regulated experience.

Responsibilities

• Coordinate CQV activities including drafting and executing IQ/OQ/PQ protocols and validation plans.
• Support technical transfer of FDP and related processes into the Ohio site, ensuring CQV deliverables are met.
• Plan and execute CQV projects with cross-functional teams (Manufacturing, Process Development, Engineering, Quality).
• Provide technical input into change control, deviations, CAPA, and risk assessments for validation.
• Identify improvements to CQV procedures and documentation templates to enhance efficiency and compliance.

Education

Master’s degree

Bachelor’s degree

Associate’s degree

High school diploma / GED

Job description

Amgen Ohio is seeking an Engineer - Process Development (CQV) to support commissioning, qualification, and validation of GMP equipment and processes enabling FDP operations. You will contribute to technical transfer, equipment startup, and continuous improvement across packaging and assembly operations.

The role requires a Master’s degree or equivalent GMP-regulated experience, with additional qualifications in CQV and cross-functional project management. Travel may be required.