(CQV) Engineer

CQV Engineer - Amgen

Are you an experienced Commissioning, Qualification & Validation (CQV) Engineer with a background in pharmaceutical manufacturing? We are seeking a skilled professional to support engineering projects and ensure equipment, systems, and processes are commissioned, qualified, and validated in compliance with GMP standards and internal procedures.

Reporting to the Senior Manager, Validation & Compliance, you will play a key role in delivering validation strategies, leading qualification activities, and supporting project teams throughout the project lifecycle.

What You'll Do

Documentation & Validation Planning

• Develop and maintain validationlifecycle documentation, including:
  • System Criticality Assessments
  • Commissioning, Qualification & Validation Plans
  • Risk Assessments
  • Test Protocols
  • Requirements Traceability Matrices
  • Validation Summary Reports

• Ensure documentation aligns with GMP requirements and internal procedures.

Commissioning, Qualification & Validation

• Lead commissioning, qualification, and validation activities.
• Execute testing activities and document results.
• Drive the successful delivery of CQV project milestones.

Technical Support

• Provide validation and compliance guidance to project teams.
• Ensure technical solutions are implemented in accordance with validation strategies and applicable SOPs.

• Support issue resolution and project risk management throughout execution.

What We're Looking For

Required Experience

• Minimum 3 years of CQV experience within pharmaceutical manufacturing.

• Hands-on experience with Secondary Packaging Systems.
• Experience with Print & Inspection Systems, such as Systech and Cognex.
• Experience with Computerised Systems Validation (CSV).
• Strong understanding of GMP-regulated environments.
• Proven experience executing commissioning and qualification activities.
• Strong technical documentation skills.

Preferred Skills

• Ability to work independently with minimal supervision
• Excellent written and verbal communication skills.

• Customer and stakeholder management experience.
• Strong analytical and critical thinking abilities.

• Ability to manage priorities and support multiple project phases simultaneously.

Why Join?

This role offers the opportunity to contribute to critical validation and compliance activities within a highly regulated pharmaceutical environment while working closely with engineering, quality, and project teams to deliver impactful technical solutions.

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