CQV Engineer: GMP Equipment & Process Development

BioSpace; New Albany (OH); On-site; USD 110,000 - 140,000; Full time

Benefits offered by this job

Total Rewards Plan

Flexible work models

Comprehensive benefits

Job summary

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

You will lead and execute IQ/OQ/PQ, participate in tech transfer, drive continuous improvement, and collaborate with Manufacturing, Process Development, Engineering and QA to ensure compliant, reliable production systems.

Qualifications

• Master's degree or equivalent experience in a GMP-regulated environment.
• Experience supporting CQV activities, protocol writing and data analysis.
• Excellent written and verbal communication with ability to work in cross-functional teams.

Responsibilities

• Complete commissioning activities and author/implement IQ/OQ/PQ protocols and lifecycle documentation.
• Maintain validated state of equipment and processes through periodic review and updates.
• Support CQV project planning, schedule alignment, and execution for new or modified equipment and systems.

Skills

Analytical thinking

Cross-functional collaboration

Problem-solving

Communication skills

Education

Master's degree

Bachelor's degree

Associates degree

High school diploma

Job description

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

You will lead and execute IQ/OQ/PQ, participate in tech transfer, drive continuous improvement, and collaborate with Manufacturing, Process Development, Engineering and QA to ensure compliant, reliable production systems.