E2E CSV/C&Q Lead — Validation Architect for Data Hub

Actalent

Basel

On-site

CHF 120,000 - 150,000

Full time

12 hours ago

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Job summary

Actalent is seeking an E2E CSV/C&Q Lead to define, coordinate, and deliver the integrated qualification and validation approach for an operations data hub, Phase 1. You will develop a modular, risk-based validation strategy spanning manufacturing source systems, OT integrations, IT infrastructure, platform services, semantic/contextualization, data products, and operational applications.

The role requires proven experience coordinating validation strategies across IT/OT, data platforms, and

Qualifications

Experience coordinating validation strategies for IT/OT/data platforms and applications.
Knowledge of GMP, CSV/CSA, C&Q and validated-state maintenance.
Ability to apply risk-based validation and intended-use principles.

Responsibilities

E2E Qualification & Validation Strategy: coordinate execution of qualification and validation activities required for production deployment of ODH
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
Define the qualification approach for Batch Traceability, Process Monitoring, Customer Data Sharing and other ODH operational applications
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.
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.