E2E CSV/C&Q Lead / E2E CSV/C&Q Leadess

Join Our Team as an E2E CSV/C&Q Lead – 7138

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Our client, a global leader in the production and process support of active pharmaceutical ingredients across both chemical and biotechnology sectors, is seeking an E2E CSV/C&Q Lead based in Basel, Switzerland for a 12-month contract with the possibility of extension.

About the Role

The E2E CSV/C&Q Lead will be responsible for defining, coordinating, and delivering the integrated qualification and validation approach for the Operations Data Hub Phase 1, which includes the Portsmouth Midscale Lighthouse and the Cross-Platform Network Assessment.

Reporting to the GE Automation Lead within the project, this role will develop a modular, fit-for-purpose, and risk-based validation strategy across the connected ODH solution. This encompasses manufacturing source systems, OT integrations, IT infrastructure, platform services, semantic and contextualization components, enterprise integrations, data products, and operational applications. The Lead will ensure that intended use, GxP relevance, system criticality, validation requirements, and end-to-end traceability are addressed consistently across relevant ISA-95 layers.

Main Responsibilities

• E2E Qualification & Validation Strategy:
  • Develop and maintain the integrated CSV/C&Q strategy for ODH Phase 1.
  • Define intended-use, GxP boundary, system classification, and validation principles across various systems.
  • Establish a reusable validation framework for Lighthouse delivery and future scale-out.
• Portsmouth Lighthouse Validation Delivery:
  • Coordinate qualification and validation activities for production deployment of ODH.
  • Ensure complete requirements traceability, testing, validation evidence, and release readiness.
  • Facilitate validation across multiple workstreams.
  • Recommend validation readiness for operational release, subject to formal approvals.
• Data Products, Traceability & Data Integrity:
  • Define the qualification approach for various ODH operational applications.
  • Ensure end-to-end traceability from business requirements through operational applications.
  • Assess and verify data integrity and compliance across connected ISA-95 layers.
• Supplier Assurance & Validation Governance:
  • Define supplier assurance and qualified component reuse strategy.
  • Ensure validation deliverables are suitable for Quality review.
  • Maintain alignment with IT and OT Quality Leads regarding their independent approval authority.
• Network Assessment Validation Blueprint:
  • Develop a reusable ODH validation blueprint and qualifications strategy for future deployments.
  • Define principles and guidance for future sites and growth projects.
  • Incorporate Lighthouse learnings into future validation standards.
• Cross-Functional Validation Leadership:
  • Align stakeholders around a common validation framework.
  • Facilitate risk assessments and validation decisions across workstreams.
  • Proactively manage validation risks and dependencies.
  • Drive a risk-based and scalable validation approach.

Required Qualifications

• Valid Swiss working/residency permit and/or Swiss/EU citizenship required.
• Bachelor's or Master's degree in Engineering, Automation, Computer Science, Information Technology, Life Sciences, Pharmaceutical Sciences, Quality Management, or a related discipline.
• Proven experience developing and coordinating validation strategies for integrated systems.
• Strong understanding of risk-based validation principles and GxP compliance.
• Broad knowledge of automation systems, MES, data platforms, and their validation implications.
• Experience in assessing data integrity, auditability, and risk management across systems.
• Knowledge of GMP, CSV/CSA, C&Q, and controlled change processes.
• Exceptional coordination skills to align diverse teams around a coherent validation approach.
• Proactive leadership to establish compliant processes without unnecessary documentation.

Apply online using the form below. Please note that only applications matching the job profile will be considered.