Senior CSV / Validation Lead (GMP Data Platforms) (m/f/d)

Our many years of recruitment experience and our expert knowledge of the engineering job market make us a strong partner for engineers and technicians. We maintain close relationships with customers across all industries and therefore can provide engineering specialists with exciting projects and attractive job opportunities, drawing on your personal interests and experience. As your professional companion, we support you throughout the entire process, from the first contact to the first day on your new job – all this completely free of charge. Register now and look forward to many interesting and suitable positions and projects.

• 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

• 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

• 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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Referenznummer
898103/1

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Telefon:+41 44 225 50 00
E-Mail: positionen@hays.ch

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