Senior CSV / Validation Lead (GMP Data Platforms)
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Job description
# Senior CSV / Validation Lead (GMP Data Platforms) # (m/f/d) Freelance/temporary employment for a project Basel Start date: asap Reference number: 898103/1 ### Responsibilities ### * Lead the end-to-end CSV and C&Q strategy for a complex GMP-regulated data environment * Define validation approaches, GxP boundaries and system classifications across interconnected IT and OT systems * Coordinate qualification and validation activities across Business, Engineering, Automation, IT/OT and Quality teams * Ensure complete requirements traceability, testing, validation evidence and release readiness * Establish risk-based validation methodologies aligned with GMP and Data Integrity requirements * Drive validation governance, supplier assurance and quality review readiness * Assess data integrity, ALCOA+ compliance, auditability and traceability across integrated systems * Develop reusable validation frameworks and standards for future site deployments * Facilitate risk assessments and validation decisions across multiple stakeholder groups * Ensure validated-state maintenance throughout the solution lifecycle ### Profile ### * Bachelor-s or Master-s degree in Engineering, Automation, Computer Science, Information Technology, Life Sciences or a related discipline * Extensive experience in Computer System Validation (CSV) and Commissioning & Qualification (C&Q) * Strong GMP and Quality Systems knowledge within pharmaceutical or biotechnology environments * Experience validating integrated IT, OT and automation systems * Strong understanding of risk-based validation methodologies and GxP requirements * Experience with data platforms, system integrations, interfaces and operational applications * Knowledge of Data Integrity principles including ALCOA+, audit trails and data lineage * Proven experience with requirements management, traceability, testing and validation documentation * Ability to coordinate complex programs involving multiple stakeholders and suppliers * Excellent communication skills and business-fluent English ### Benefits ### * Join a strategic digital transformation program with high visibility and business impact * Work on innovative data platforms and next-generation manufacturing technologies * Collaborate with global cross-functional teams across Business, Quality, Engineering, Automation and IT * Influence validation standards and deployment models for future global rollouts * Take ownership of a highly visible leadership role within a regulated environment * Shape scalable validation frameworks that support long-term growth and expansion * Gain exposure to complex IT, OT, automation and data ecosystems * Work in an international environment focused on innovation, compliance and operational excellence
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