Senior CSV / Validation Lead (GMP Data Platforms)

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