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Open nowPosted 2 days ago

Senior CSV / Validation Lead (GMP Data Platforms)

job-room.ch119,207 open roles

Where
BASEL, BS, Switzerland
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Your applicationOpen nowSenior CSV / Validation Lead (GMP Data Platforms)job-room.ch · BASEL, BS, Switzerland

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  5. 34.1%30 days
This job: posted 2 days ago

job-room.ch median: 5 days open

The posting

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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