CQV Engineer - Support Equipment

The CQ Engineer will execute the commissioning and qualification (C&Q) of support equipment—specifically autoclaves, washers, and clean utility systems (WFI, PW, Clean Steam, Nitrogen). This role ensures equipment and systems are installed, commissioned, and qualified in line with regulatory and project requirements, supporting the delivery of safe, compliant, and robust manufacturing operations.

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• Perform end-to-end C&Q activities for autoclaves, washers, and clean utilities (e.g., purified water, clean steam, nitrogen).
  
• Prepare, execute, and review commissioning and qualification protocols (DQ, IQ, OQ, PQ) and related documentation.
  
• Support installation, functional testing, and troubleshooting for support equipment and utilities.
  
• Collaborate with project teams, vendors, and contractors to ensure technical deliverables and documentation are complete and compliant.
  
• Participate in FAT (Factory Acceptance Test) and SAT (Site Acceptance Test) for assigned equipment.
  
• Ensure alignment with regulatory requirements such as cGMP, FDA, EudraLex, and internal SOPs.
  
• Maintain up-to-date project files and support change control processes.
  
• Identify and elevate technical or project risks, supporting investigation and resolution.
  
• Ensure proper calibration and verification of critical system instruments.
  
• Support or lead training and knowledge transfer sessions for operators or maintenance personnel.
  

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• Bachelor’s degree in Engineering, Life Sciences, or a related technical discipline preferred.
  
• Minimum 4 years hands‑on experience in commissioning, qualification, and validation of pharmaceutical support equipment or utilities.
  
• Proven experience qualifying autoclaves, washers, and clean utility systems (WFI, PW, Clean Steam, N2).
  
• Knowledge of validation lifecycle, GMP regulations, and quality systems.
  
• Familiarity with GAMP and other qualification guidelines.
  
• Experience working with external vendors and managing documentation for audits.
  
• Good troubleshooting, organizational, and communication skills. xcfaprz
  
• Detail‑oriented, proactive, hands‑on work approach.