CQV Engineer – Equipment Validation for Sterile Manufacturing

About the role

The CQV Engineer will support the qualification, validation and ongoing maintenance of pharmaceutical equipment, utilities and systems used in sterile injectable manufacturing. The role ensures compliance with cGMP, FDA, EMA and Annex 1 requirements while collaborating with cross‑functional teams to keep the manufacturing environment ready for production.

Key responsibilities

• Develop, execute and review Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) protocols for sterile manufacturing equipment.
• Assist in creating User Requirements Specifications (URS) and Requirements Traceability Matrix (RTM) for equipment and automated systems.
• Perform risk assessments such as FMEA to define validation strategies and critical parameters.
• Maintain the validated state of equipment, clean utilities (WFI, clean steam, compressed air, HVAC) and process support systems.
• Qualify aseptic filling lines, lyophilizers, autoclaves, depyrogenation tunnels and isolator/RABS systems.
• Support validation of automation and control systems including SCADA, PLC and MES.
• Author and review validation documentation (VMPs, protocols, reports) and provide data for audits and regulatory inspections.
• Investigate validation deviations, implement CAPAs and assess impact of equipment modifications.
• Apply Lean and Six Sigma principles to streamline validation processes and support technology upgrades.

Required profile

• Bachelor’s degree in engineering, life sciences or a related discipline.
• Experience with equipment qualification and validation in a regulated pharmaceutical environment.
• Strong knowledge of cGMP, FDA, EMA and Annex 1 validation requirements.
• Ability to conduct risk assessments and manage deviation investigations.

Required skills

• IQ, OQ and PQ protocol development and execution.
• FMEA risk assessment methodology.
• Clean utilities qualification (WFI, clean steam, compressed air, HVAC).
• Automation and control systems knowledge (SCADA, PLC, MES).
• Lean and Six Sigma process improvement techniques.