CQV Lead

About the Role
We are seeking an experienced CQV Lead to support a major capital project within the pharmaceutical industry. The successful candidate will provide technical leadership and day-to-day coordination of commissioning, qualification and validation activities, ensuring that project deliverables meet regulatory requirements, quality standards and project milestones. The role will involve working closely with engineering teams, contractors, vendors and project stakeholders to ensure the successful delivery and handover of systems and equipment.

Key Responsibilities
• Lead and coordinate day-to-day commissioning and qualification activities across project systems and equipment.
• Coordinate engineers, subject matter experts, contractors and external vendors.
• Support the development and execution of C&Q strategies, plans, schedules and project deliverables.
• Oversee the preparation, review and execution of qualification protocols, testing documentation and final reports.
• Ensure documentation meets GMP requirements and maintains appropriate traceability and compliance.
• Apply risk-based approaches to commissioning and qualification activities.
• Support the management and resolution of deviations, non-conformances and outstanding project items.
• Coordinate factory and site acceptance testing, system turnover and operational readiness activities.
• Monitor project progress, identify potential risks and provide regular updates to project leadership.
• Support audits, inspections and final project handover activities. Requirements
• Bachelor's degree in Engineering, Life Sciences or a related discipline.
• Minimum of 7 years' experience in commissioning, qualification, validation or engineering within a regulated industry.
• Previous experience leading or coordinating C&Q activities on pharmaceutical capital projects.
• Strong understanding of pharmaceutical facilities, utilities, HVAC systems and process equipment.
• Knowledge of GMP regulations and relevant industry standards and guidelines.
• Familiarity with risk-based qualification approaches and commissioning methodologies.
• Experience with qualification protocols, deviations, change controls and technical documentation.
• Strong leadership, stakeholder management and communication skills.