CQV Engineer

The CQV Engineer will support commissioning, qualification, and validation activities within GMP-regulated pharmaceutical manufacturing facilities. The role is responsible for executing qualification activities, ensuring equipment, utilities, systems, and processes meet regulatory requirements, and supporting project delivery through accurate documentation, testing, and cross-functional coordination.

• Prepare, review, and execute CQV documentation, including IQ, OQ, PQ protocols, test scripts, and final reports.
• Perform on-site commissioning, qualification testing, system walk-downs, and verification activities for GMP equipment, utilities, and process systems.
• Review engineering drawings, design specifications, equipment manuals, SOPs, and vendor documentation to ensure compliance with project requirements and GMP standards.
• Identify, document, and support resolution of gaps, deviations, discrepancies, and non-conformances.
• Support root cause analysis, corrective actions, change control, and risk assessment activities.
• Coordinate with quality, engineering, manufacturing, validation, contractors, and client project teams to meet project timelines.
• Ensure all CQV activities are performed in accordance with FDA, EU GMP, GxP, and company quality requirements.
• Provide regular project status updates, technical inputs, and documentation support to stakeholders.

• Strong knowledge of GMP, GxP, FDA, and EU GMP regulatory requirements.
• Hands-on experience with IQ, OQ, PQ, commissioning, qualification, and validation activities.
• Good understanding of pharmaceutical manufacturing equipment, utilities, and cleanroom-controlled systems.
• Ability to prepare and review protocols, reports, test scripts, SOPs, and technical documentation.
• Experience in deviation management, change control, CAPA, risk assessment, and root cause analysis.
• Strong attention to detail and documentation accuracy.
• Good communication and coordination skills with cross-functional teams.
• Ability to work in fast-paced, on-site project environments.
• Knowledge of validation lifecycle, data integrity, and quality compliance practices.