Commissioning Qualification Technical Lead

• Lead and manage the full CQV lifecycle: planning, documentation, execution, and handover to the Client USER team.
• Develop and maintain the overall CQ plan and system-based CQV schedule.
• Coordinate multidisciplinary teams including engineering, construction management (CM), automation, CSV, vendors, contractors, and operations.
• Oversee CQV documentation preparation, review, approval workflows, and execution readiness.
• Manage FAT and SAT support activities.
• Ensure Mechanical Completion (MC) and Automation readiness prior to CQ execution.
• Lead daily CQV coordination meetings during execution phases.
• Manage deviations, change control, punch lists, and system handover activities.
• Ensure compliance with qualification standards and leverage FAT/SAT documentation where applicable.
• Oversee HSE compliance, including Safe Start-Up and LOTO readiness.
• Track project milestones, cost, man-hours, and schedule adherence.
• Provide progress reporting and support contract/vendor management activities.
• Support PQ and PPQ activities as required.

• Knowledge of engineering disciplines, commissioning, compliance, qualification and qualify aspects of biopharma or pharmaceutical manufacturing.
• Minimum 10 years of experience in Process Commissioning & Qualification (CQV).
• Strong experience in GMP-regulated pharmaceutical or biopharmaceutical environments.
• Proven experience leading multidisciplinary CQV teams.
• Strong understanding of compliance, quality systems, and regulatory expectations.
• Fluent in English (written and spoken).

• Commissioning & Qualification: System definition and classification, CQ strategy development, FAT/SAT, IQ/OQ support, deviation and change control management.
• Process Equipment: Commissioning and qualification of process and process support systems.
• Project Controls: Baseline scheduling, cost control, progress reporting, resource planning.
• Compliance & Quality: GMP, HSE, documentation management, inspection readiness.
• Leadership: Cross-functional coordination, vendor management, client-facing communication.

Powered by JazzHR