CQV Engineer

Our client is a global pharmaceutical organization with a GMP manufacturing environment. The site Engineering organization supports technical projects that ensure reliable, compliant, and efficient manufacturing operations.

Role Description

As a CQV Engineer, you support technical projects from commissioning through qualification and validation. You develop and execute test strategies, prepare CQV documentation, and provide technical guidance to project teams to ensure systems meet customer requirements and GMP standards.

Key Responsibilities

• Develop and maintain CQV documentation, including validation plans, risk assessments, protocols, and reports
• Lead commissioning, qualification, and validation activities
• Develop test strategies and execute qualification testing
• Support project teams with CQV and GMP guidance
• Ensure technical solutions align with validation requirements and procedures
• Track project activities, issues, and timelines
• Report progress and escalate issues when required

Requirements

• Minimum 3 years of CQV experience within pharmaceutical manufacturing
• Hands-on commissioning and qualification experience in secondary packaging operations
• Experience with print and inspection systems, such as Systech or Cognex
• Experience with Computerized Systems Validation (CSV)
• Strong knowledge of GMP validation practices
• Experience developing validation and qualification documentation
• Good technical writing skills in English
• Strong communication and stakeholder management skills
• Able to work independently with limited supervision
• Strong analytical and problem-solving skills

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