(CQV) Engineer

As a CQV Engineer at Amgen, you support validation strategies across pharmaceutical manufacturing, ensuring equipment, systems and processes are commissioned, qualified, and validated in GMP-compliant ways. You collaborate with engineering, quality, and project teams to deliver CQV milestones and provide technical guidance. You will shape validation deliverables and risk-based decisions in a highly regulated environment. This role offers meaningful impact by enabling compliant, efficient project execution and robust technical solutions.

• Develop and maintain validation lifecycle documentation (System Criticality Assessments, CQV Plans, Risk Assessments, Test Protocols, Requirements Traceability Matrices, Validation Summary Reports)
• Lead commissioning, qualification and validation activities and document results
• Deliver CQV project milestones and provide technical guidance to project teams
• Support issue resolution and risk management throughout execution
• Ensure alignment of documentation with GMP requirements and internal SOPs

• Minimum 3 years of CQV experience in pharmaceutical manufacturing
• Hands-on experience with Secondary Packaging Systems
• Experience with Print & Inspection Systems (Systech, Cognex)
• Experience with Computerised Systems Validation (CSV)
• Strong GMP knowledge and experience executing CQV activities
• Strong technical documentation skills

• Independent with minimal supervision
• Excellent written and verbal communication
• Customer and stakeholder management
• CQV planning and execution
• Documentation and technical writing
• Risk assessment and validation planning