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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 supportCQV 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 activelyparticipatein the Community of Excellence (CoE)
Lead Communities of Practice (CoPs) across sites
Partner with Global Quality,Eng, and site functions to ensurealignedandinspection ready
CQV Execution & Project Delivery
Ensure consistent and compliant execution of CQV activities across CAPEX projectsSupport 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 whilemaintainingclear 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 andmaintainedin a compliant state
Compliance Engineering
Support implementation of Compliance Engineering frameworks, standards, andinitiativesatsitelevel, including support for inspection readiness and site preparedness
Actassiteinterfacefor Compliance Engineeringtopics,ensuringcoordinationandalignmentbetweensitesand globalfunctions
Provide feedback, input, andlessonslearnedfromsitesto global ComplianceEngineering
PaperlessValidation
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 ValidationLeadto 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 sitesand within Global Engineering
Digital Validation, Innovation & Continuous Improvement
Drive adoption of digital and paperlessvalidationsolutions.
Lead global and site-levelinitiativestoenhanceefficiency,quality, andstandardizationacrossCSV & OT compliance.
What you bring to Takeda:
Required
Degree in engineeringorpharmaceuticalscienceorequivalent
ExperiencemanagingCQVactivitiesinmajorCAPEXprojects
Languages Businessfluentproficiencyin English
Experience:5+yearsin CQV, GMP-regulatedprojectmanagement,oroperations inthepharmaceuticalindustry
StrongknowledgeofGxP,CQVprocessesandvalidationlifecycle
High communicationskills,analyticalmindset,abilitytoworkunderpressure
Strongcollaborationandstakeholdermanagementskills
Preferred
Experience in Manufacturingoroperations
Experiencewithdigitalvalidationtools
Zurich, Switzerland
Base Salary Range:
CHF159,300.00 - CHF219,010.00
For information about our benefits, please click here
Employee
Regular
Full time
We strive to transform lives. While the science we advance is constantly evolving, our core purpose is enduring. For more than two centuries, our values have guided us to do what’s right for patients and for society.
We know that changing lives requires us to do things differently. We start by listening to and addressing what really matters to patients, the people who love them, and those in the healthcare system who provide care. And that’s what inspires us all to be bold, push boundaries and set new standards that open up greater opportunities.
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