CSV / C&Q Lead

Actalent; Basel; On-site; CHF 120,000 - 150,000; Full time

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.

Skills

Validation strategy

IT/OT integration

GxP knowledge

Data validation

Education

Bachelor/Master in Engineering/Automation/CS/IT/Life Sciences/Pharma/Quality

Tools

MES

Historians

Integration platforms

Enterprise apps

Job description

We are looking for an E2E CSV/C&Q Lead to define, coordinate, and deliver the integrated qualification and validation approach for an operations data hub, Phase 1.

This role will develop a modular and risk-based validation strategy, including manufacturing source systems, OT integrations, IT infrastructure and platform services, semantic and contextualization components, enterprise integrations, data products, and operational applications.

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.

Requirements:

• Degree (required)* Bachelor or Master: 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 spanning IT, OT, data platforms and operational applications
• Strong ability to apply intended-use, GxP impact, system criticality and risk-based principles to determine proportionate validation controls
• Broad knowledge of automation, MES, historians, infrastructure, integration platforms, enterprise applications and their validation implications
• Experience validating data flows, transformations, interfaces, contextualization logic, data products and software applications used in regulated operations
• Strong knowledge of GMP, CSV/CSA, C&Q, controlled change, deviations, CAPA and validated-state maintenance

*Please note that we can only consider EU/Schengen applications, or valid Swiss permit.