By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description About the role: Lead and coordinate CQV and Compliance Engineering activities across a defined region, ensuring compliant, efficient, and standardized execution across CAPEX projects and lifecycle phases, including support for inspection readiness and site preparedness. Ensure execution of CQV activities (Commissioning, Qualification & Validation) across CAPEX projects and lifecycle in alignment with global strategies and standards. Support and enable the use of paperless validation systems across sites. Drive continuous improvement, innovation, and digitalization in CQV and Compliance Engineering, including AI- and data-driven approaches. How you will contribute: Strategy, Governance & Leadership Actively lead and support CQV and Engineering Compliance strategy Act as Single Point of Contact ( SPoC ) for sites for CQV and Compliance Engineering topics Coordinate and oversee CQV and Compliance Engineering activities across assigned sites Drive and implement global initiatives and ensure implementation at site level Contribute to and actively participate in the Community of Excellence ( CoE ) Lead Communities of Practice (CoPs) across sites Partner with Global Quality, Eng , and site functions to ensure aligned and inspection ready . CQV Execution & Project Delivery Ensure consistent and compliant execution of CQV activities across CAPEX projects : Support planning and coordination of CQV activities to meet timelines and regulatory expectations Ensure alignment with global CQV standards and regulatory requirements Collaborate with CSV / OT while maintaining clear accountability boundaries (no ownership of equipment qualification such as IQ/OQ/PQ). Validation Maintenance Lead and ensure implementation of validation maintenance across sites Ensure lifecycle validation activities (e.g., periodic review and requalification) are executed and maintained in a compliant state Compliance Engineering Support implementation of Compliance Engineering frameworks, standards, and initiatives at site level , including support for inspection readiness and site preparedness Act as site interface for Compliance Engineering topics , ensuring coordination and alignment between sites and global functions Provide feedback, input, and lessons learned from sites to global Compliance Engineering Paperless Validation Act as regional key contact for paperless validation systems Support and enable effective use of digital validation tools across sites Support system adoption, onboarding, and usage Drive adoption and consistent use of digital and paperless validation solutions Act as back-up for the Global Paperless Validation Lead to ensure continuity of operations and support Continuous Improvement & Innovation Drive continuous improvement and standardization of CQV and Compliance Engineering activities across sites Lead implementation of innovation and digitalization initiatives (e.g., AI-driven approaches) at site level Promote best practice sharing and harmonization across sites and within Global Engineering Digital Validation, Innovation & Continuous Improvement Drive adoption of digital and paperless validation solutions. Lead global and site- level initiatives to enhance efficiency , quality , and standardization across CSV & OT compliance. What you bring to Takeda: Required Degree in engineering or pharmaceutical science or equivalent Experience managing CQV activities in major CAPEX projects Languages : Business fluent proficiency in English Experience: 5 + years in CQV, GMP- regulated project management , or operations in the pharmaceutical industry Strong knowledge of GxP , CQV processes and validation lifecycle High communication skills , analytical mindset , ability to work under pressure Strong collaboration and stakeholder management skills Preferred Experience in Manufacturing or operations Experience with digital validation tools Locations Zurich, Switzerland Base Salary Range: CHF159,300.00 - CHF219,010.00 For information about our benefits, please click here . Worker Type Employee Worker Sub-Type Regular Time Type Full time
Region CQV Lead, Europe/Asia
takeda
CH
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