E2E CSV/C&Q Lead (7138)

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Global Market Leader in Active Pharmaceutical Ingredients

Our client, a global market leader in the production and process support of active pharmaceutical ingredients across chemical and biotechnology sectors, is seeking a professional based in Basel, Switzerland for a 12-month contract with the possibility of extension.

Role Overview

The position is responsible for defining, coordinating, and delivering the integrated qualification and validation approach for Operations Data Hub Phase 1. This covers the Portsmouth Midscale Lighthouse and the Cross-Platform Network Assessment. Reporting within the project to the GE Automation Lead, the role develops a fit-for-purpose, modular, and risk-based validation strategy across the connected ODH solution. This includes manufacturing source systems, OT integrations, IT infrastructure, platform services, semantic and contextualization components, enterprise integrations, data products, and operational applications. The role ensures that intended use, GxP relevance, system criticality, validation requirements, and end-to-end traceability are consistently addressed across the relevant ISA-95 layers.

The role coordinates validation activities and deliverables across Business, GE, IT/OT, Automation, and external partners, ensuring the overall validation package is complete, internally consistent, and ready for Quality review. The IT and OT Quality Leads provide independent oversight and retain final approval authority for their respective areas.

For the Network Assessment, the role establishes a reusable validation blueprint, qualification archetypes, and an effort model to support future site deployments and growth projects. The eCAR identifies a risk-based qualification strategy, end-to-end traceability, data integrity, interoperability, ALCOA+, controlled changes, and formal Quality approval as key requirements before ODH can support GMP-relevant operational decision-making.

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 source systems, integrations, platform services, data products, and operational applications.
  • Establish the reusable validation framework and qualification approach for both Lighthouse delivery and future scale-out.
• Portsmouth Lighthouse Validation Delivery
  • Coordinate execution of qualification and validation activities required for production deployment of ODH at Portsmouth Midscale.
  • Ensure complete requirements traceability, testing, validation evidence, data integrity, and release readiness across the end-to-end solution.
  • Coordinate validation deliverables across Business, Engineering, Automation, IT/OT, Semantic, and Application workstreams.
  • Recommend validation readiness for operational release, subject to business acceptance and formal IT and OT Quality approval.
• Data Products, Traceability & Data Integrity
  • Define the qualification approach for Batch Traceability, Process Monitoring, Customer Data Sharing, and other ODH operational applications.
  • Ensure end-to-end traceability from business requirements through source systems, integrations, semantic models, platform services, and operational applications.
  • Assess and verify data integrity, ALCOA+ compliance, auditability, and data lineage across connected ISA-95 layers.
• Supplier Assurance & Validation Governance
  • Define the supplier assurance, testing reliance, and qualified component reuse strategy for ODH technologies and implementation partners.
  • Ensure validation deliverables are complete, internally consistent, and suitable for Quality review.
  • Facilitate alignment with IT and OT Quality Leads while recognizing their independent approval authority.
  • Ensure validated-state maintenance requirements are embedded within the ODH operating model.
• Network Assessment Validation Blueprint
  • Develop the reusable ODH validation blueprint, qualification strategy, and qualification archetypes for future deployments.
  • Define intended-use principles, GxP-boundary guidance, system classification approaches, minimum validation deliverables, and validation prerequisites for future sites and growth projects.
  • Establish validation effort, resource, schedule, and cost models to support future rollout planning and cost estimation.
  • Incorporate Lighthouse learnings into future validation standards and deployment assumptions.
• Cross-Functional Validation Leadership
  • Align Business, Architecture, Automation, IT/OT, Quality, and Engineering stakeholders around a common validation framework.
  • Facilitate risk assessments, intended-use evaluations, and validation decisions across workstreams.
  • Ensure program-level validation risks, dependencies, and issues are proactively managed and escalated.
  • Drive a pragmatic, risk-based, and scalable validation approach that balances compliance, operational needs, and future scalability.

Required Qualifications

• Relevant Swiss working/residency permit and/or Swiss/EU-Citizenship required.
• Degree (required): Bachelor or Master in Engineering, Automation, Computer Science, Information Technology, Life Sciences, Pharmaceutical Sciences, Quality Management, or a related discipline.
• E2E CSV and Qualification Delivery: Proven experience developing and coordinating validation strategies for integrated systems spanning IT, OT, data platforms, and operational applications.
• Risk-Based Validation: Strong ability to apply intended-use, GxP impact, system criticality, and risk-based principles to determine proportionate validation controls.
• IT and OT Systems Understanding: Broad knowledge of automation, MES, historians, infrastructure, integration platforms, enterprise applications, and their validation implications.
• Data Platforms and Operational Applications: Experience validating data flows, transformations, interfaces, contextualization logic, data products, and software applications used in regulated operations.
• Requirements and Traceability Management: Strong knowledge of requirements development, traceability matrices, risk assessments, testing strategies, and controlled validation documentation.
• Data Integrity and ALCOA+: Practical experience assessing data lineage, transformations, interfaces, auditability, access controls, and data-integrity risks across integrated systems.
• Supplier and Platform Assurance: Experience assessing supplier capabilities and appropriately leveraging vendor documentation, testing, and qualified platform services.
• GMP and Quality Systems: Strong knowledge of GMP, CSV/CSA, C&Q, controlled change, deviations, CAPA, and validated-state maintenance.
• Cross-Functional Coordination: Ability to align Business, Quality, IT, OT, Engineering, system owners, and external partners around one coherent validation approach.
• Pragmatic Compliance Leadership: Ability to establish a compliant and defensible approach without creating unnecessary documentation, duplicated testing, or avoidable requalification.