CQV Lead

The CQV Lead – Fill Finish (Optima) is responsible for leading the commissioning, qualification, and validation activities for fill-finish operations, with a primary focus on Optima filling and packaging lines. This role ensures all equipment and processes are installed, commissioned, and qualified in compliance with regulatory standards and project objectives. The CQV Lead will manage technical teams, maintain stakeholder communication, and ensure audit-ready documentation for successful project delivery.

Key Responsibilities

• Lead end-to-end CQV activities for Optima fill-finish lines, including installation, commissioning, qualification, and validation.
• Develop and review CQV documentation: URS, DQ/IQ/OQ/PQ protocols, validation plans, risk assessments, and reports.
• Coordinate FAT and SAT with Optima and other relevant suppliers and contractors.
• Work closely with project engineering, operations, quality assurance, and automation teams to ensure seamless CQV integration.
• Plan, monitor, and control project CQV schedules, resources, and milestones.
• Support troubleshooting and technical investigations during commissioning and qualification.
• Ensure strict adherence to regulatory standards (cGMP, FDA, EudraLex, GAMP) and project requirements.
• Identify, elevate, and resolve project risks, deviations, and change controls.
• Supervise, mentor, and support CQV engineers, specialists, and site staff.
• Prepare and maintain audit-ready, compliant documentation for regulatory inspections.
• Drive continuous improvement through lessons learned and best practice sharing.

Qualifications & Experience

• Bachelor’s degree in Engineering, Life Sciences, or related technical field (Master’s preferred).
• Minimum 8 years CQV experience in pharmaceutical fill-finish manufacturing, with direct involvement in Optima filling/packaging lines.
• Detailed understanding and hands-on experience with commissioning and qualification of Optima equipment (installation, URS, protocols, troubleshooting).
• Strong grasp of pharmaceutical manufacturing regulatory compliance (cGMP, FDA, EudraLex, GAMP, ASTM E2500).
• Project and team leadership experience within sterile manufacturing or fill-finish environments.
• Exceptional organizational, communication, and stakeholder management skills.