Project Leader

Key Responsibilities

• Lead qualification and validation activities (IQ/OQ/PQ) for pharmaceutical clean rooms
• Define project scope for new and existing areas, including rooms, HVAC, utilities, and impacted systems
• Collect, review, and assess existing GMP documentation (layouts, flow concepts, previous qualifications)
• Perform GxP risk assessments related to cleanroom changes and equipment relocation
• Define and execute the qualification strategy for new and modified environments
• Determine re-qualification and testing requirements following equipment relocation
• Develop and manage project timelines, milestones, and execution plans
• Prepare and maintain the Qualification Master Plan (QMP), including acceptance criteria and regulatory references
• Coordinate and align activities with QA, Engineering, Production, and Automation/IT teams
• Ensure compliance with GMP, GxP, and internal quality standards

If you are interested and believe you are a good fit, do not hesitate to contact us. We are looking for an experienced Project Leader / Validation Lead to manage the qualification and validation of pharmaceutical cleanroom environments within a GMP-regulated setting. The role focuses on floor-to-floor equipment relocation, cleanroom qualification, and coordination of all related GMP validation activities. You will act as the central interface between Quality Assurance, Engineering, Operations, Production, and Automation/IT, ensuring compliance, quality, and timely delivery.