Manpower 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. Key Responsibilities - Lead qualification and validation activities (IQ/OQ/PQ) for pharmaceutical cleanrooms - 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 Required Qualifications & Experience - Strong hands-on experience in cleanroom qualification and validation within pharma or biotech environments - Proven expertise in IQ / OQ / PQ, GMP documentation, QMP and/or VMP - Experience with HVAC systems, utilities, and equipment relocation projects - Solid background in GMP / GxP regulated environments - Demonstrated project leadership and stakeholder management skills - Ability to work independently in complex, highly regulated settings - Fluent German and English (spoken and written) - Willingness to work on-site in Schaffhausen 4 days per week If you are interested and believe you are a good fit, do not hesitate to contact us. Branche: Pharma-Industrie Funktion: Technologie/EDV